FDA Updates



Recent Postings from FDA

January 7, 2019

2018 New Drug Therapy Approvals Report

Today, the U. S. Food and Drug Administration released Advancing Health through Innovation: 2018 New Drug Therapy Approvals, a summary of the Center for Drug Evaluation and Research’s (CDER’s) 2018 important new drug approvals that serve to bring innovative new drug therapies that are safe and effective to patients in need. While CDER approved 59 novel drugs in 2018, more than in any prior year, CDER, as always, focuses on the medical value of the approvals, not the number. We also approved new uses, new formulations, and new dosage forms for many already FDA-approved drugs that will help to advance patient care. This report emphasizes the many innovative regulatory tools CDER uses to enhance our efficiency and expedite the review and approval of drug therapies never marketed in the U.S. and that all these drugs were approved by or well before their goal dates as determined by the Prescription Drug User Fees Act (PDUFA).

December 20, 2018

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic – Drug Information Update

Today, the U.S. Food and Drug Administration (FDA) published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.” The list includes approved new drug applications (NDAs) for drug products that are not protected by patents or exclusivities at the time of the update, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. Both PDF and Excel formats are available.

December 10, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

read it here

November 30, 2018

FDA Stakeholder Update - November 30, 2018

FDA’s 2018 Strategic Policy Roadmap, identified four priority areas that help further our commitment to advance public health and over the past week, FDA has had some notable news and statements that are important to highlight. The four key priority areas are:

  • Reduce the burden of addiction crises that are threatening American families
  • Leverage innovation and competition to improve health care, broaden access, and advance public health goals
  • Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease
  • Strengthen FDA’s scientific workforce and its tools for efficient risk management
Read More

November 19, 2018

FDA Voice FDA is Advancing New Efforts to Address Drug Shortages

Ensuring that a necessary drug is available to a patient involves a lot of stakeholders working together at key stages of the development, manufacturing, marketing, and distribution of a medicine. This collaboration and coordination also applies when we work together to curtail a shortage.
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Annual Report on the Status of Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs) for FY2017 now available

Today the Food and Drug Administration released the Annual Report on the Status of Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs) for FY2017.
FDA is pleased to report that the majority of the PMRs/PMCs in the FY2017 report were successfully completed (fulfilled) or are progressing toward completion according to the original schedule; very few PMRs/PMCs are considered ‘delayed.’ Additionally, the FY2017 Report to Congress on the Backlog of PMRs/PMCs shows that progress continues to be made in closing out PMRs/PMCs in the "backlog.”

November 14, 2018

Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication

Today, the U.S. Food and Drug Administration issued a Safety Communication titled “Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication.” The FDA is sharing important information with health care providers, pharmacists, compounders, patients, and caregivers about the risks of using medications delivered into the spinal fluid to treat or manage pain that are not approved for use with the implanted pumps.

November 9, 2018

FDA highlights record-breaking number of generic drug approvals in October

The U.S. Food and Drug Administration is providing a summary of the generic drug approval actions for the month of October 2018 as part of its efforts to improve patient access to high-quality, lower cost, safe and effective medicines.

FDA STATEMENT: FDA modernizing inspections for sterile injectible drugs

Today we’re taking new steps to modernize our inspections program with a new way of assessing, recording and reporting the data from surveillance and pre-approval inspections for sterile drug products.
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October 17, 2018

Fall 2018 Unified Agenda: FDA’s New Regulatory Work to Advance Health and Safety

Today, the federal government published the Fall 2018 Unified Agenda, which provides federal agencies the opportunity to share the government’s top regulatory priorities with the American public. For the U.S. Food and Drug Administration (FDA), the Agenda reflects our ongoing commitment to protecting and promoting the public health through science-based decision-making that informs new regulations that advance the public health and promote innovative, efficient oversight of our key areas of influence.

October 2, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

When I announced the Drug Competition Action Plan, or DCAP, in June 2017, I committed the FDA to a number of new steps to increase competition in the market for prescription drugs and to help facilitate the entry of lower-cost alternatives to improve patient access to affordable medicines.
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Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

This guidance is intended for firms that have registered with the Food and Drug Administration (FDA) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as human drug compounding outsourcing facilities (outsourcing facilities). Under section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).”2 This guidance explains FDA’s current thinking on adverse event reporting for outsourcing facilities.

September 27, 2018

Compounding Risk Alert: Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors

The U.S. Food and Drug Administration has received reports of dosing errors and confusion with the labeled strength expression for certain compounded injectable products. Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently. Below is a description of the case reports received by FDA. The case reports illustrate how differences in the product labels of conventional manufacturers and compounders may lead to dosing errors.
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Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Good morning and welcome. I am Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis here at the Food and Drug Administration.
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Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations

This week marks the official start of “flu season” for 2018-2019. The FDA, along with its partners across the Department of Health and Human Services, has been working throughout the year to prepare the development of a safe, effective flu vaccine for the season. I’ll be getting my flu shot this week at an event in Washington, along with the U.S. Surgeon General Jerome M. Adams. With the severity of last year’s flu season, I know that there are questions about the effectiveness and benefits of the flu vaccine.
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FDA announces new and expanded compounding research projects- Drug Information Update

FDA is announcing an agreement with the National Academies of Science, Engineering & Medicine (NASEM), and expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation (CERSIs). These institutions will conduct research to help inform the public and the agency’s policies regarding compounded drugs.
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September 20, 2018

New Drug Safety Podcasts: Drug Shortages - Drug Information Update

FDA has released the latest edition of the Director’s Corner Podcast. In this podcast, Dr. Woodcock discusses what the agency is doing to address the issue of drug shortages, and how it is working with industry to help lessen their impact.

Listen to Podcast

FDA In Brief: FDA advances policies related to bolstering security of drug products in the U.S. supply chain

Today, the FDA is finalizing two guidance documents and making available one draft guidance to help ensure that prescription drug products are identified and traced properly as they move through the supply chain in compliance with federal law. The goal of these documents laying out the FDA’s policies is to clarify for the pharmaceutical industry timing related to product identification, and verification, to reduce confusion in the supply chain and ensure compliance.
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August 22, 2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics

As we all work to confront the staggering human and economic toll created by the opioid crisis, we recognize the critical role that health care providers play in addressing this public health priority – both in reducing the rate of new addiction by decreasing unnecessary and/or inappropriate exposure to opioids and ensuring rational prescribing practices, while still providing appropriate treatment to patients who have medical need for these medicines. With millions of Americans misusing and abusing opioids and more than 40 people dying every day from overdoses involving prescription opioids, it’s clear that we need to do everything we can, including working with stakeholders, to get ahead of this crisis.
Continue reading

August 16, 2018

FDA approves first generic version of EpiPen

The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.
Continue reading

August 8, 2018

FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

The U.S. Food and Drug Administration approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment that is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible. Continue reading

See FDA News Release

FDA Launches New Medication Guide Database

FDA has launched a new Medication Guide database to replace the current Medication Guide web page. Medication guides are provided with many prescription medicines. A Medication Guide is a form of patient labeling that is part of the FDA-approved prescription drug labeling. Medication Guides address issues that are specific to particular prescription drugs or biologic products and can help patients avoid serious adverse events.

July 23, 2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

Today, the FDA issued a compounding risk alert to warn health care providers, compounders and patients of the dangers of using the bulk drug substance cesium chloride. Cesium chloride is sometimes used by cancer patients despite never having been proven safe and effective for any use. Serious adverse events associated with the use of cesium chloride and other cesium salts include abnormal heart rhythms (arrhythmias), low potassium (hypokalemia), seizures, fainting (syncope), cardiac arrest and death.

See FDA Release

July 18, 2018

FDA Releases Biosimilars Action Plan - Drug Information Update

Today, FDA released the Biosimilars Action Plan (BAP) to provide information about the key actions the agency is taking to encourage innovation and competition among biologics and the development of biosimilars. The BAP is focused on four key areas:

  1. improving the efficiency of the biosimilar and interchangeable product development and approval process;
  2. maximizing scientific and regulatory clarity for the biosimilar product development community;
  3. developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors; and
  4. supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.

See FDA Release

July 12, 2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages

We’ve seen the number of new drug shortages steadily decline since a peak in 2011 owing to the work of the FDA, industry and other groups. Despite these efforts, we continue to see ongoing shortages of medically necessary products. Even shortages of a small number of key drugs can place a serious burden on providers. While we’ve made progress to mitigate individual shortages, we haven’t firmly impacted the underlying structural concerns that give rise to these recurring challenges. When shortages occur, practitioners are forced to ration supplies or substitute alternate drugs that in some cases compromise patient care. We need to pursue more enduring solutions.
Continue reading

June 22, 2018

FDA Announcement related to opioids

Addressing opioid addiction is one of the FDA’s highest priorities and supports the U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis. The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioids. The agency will also continue to evaluate how opioids currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.

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Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

Among the biggest challenges health care providers and patients face are shortages of medically necessary medications. These shortages greatly impact patient treatment options and require practitioners to make difficult decisions that can compromise care, such as rationing supplies or using less desirable, but more readily available, alternative therapies. The FDA also understands the impact and concern these shortages may have on patients and we want to reassure them that their care will continue to be our priority.

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June 12, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

More patients have more opportunities to benefit their health. But to realize the potential of these scientific advances, American patients must be able to gain access to these innovations. That means they must be able to afford the resulting medicines. And the rising list prices of drugs can create an obstacle to access. This is especially true for patients who find themselves underinsured or uninsured for medicines.
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June 6, 2018

FDA Voice FDA’s New Efforts to Advance Biotechnology Innovation

Scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human and animal health, animal welfare, and food security. And researchers and companies based in the United States helped pioneer these technologies. They position the U.S. as a global leader of this rapidly growing and highly promising field.
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June 4, 2018

FDA Voice Blog: Proposed Modernization of FDA’s Drug Review Office

FDA has proposed an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs. These changes are intended to free up resources so that our scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities. The proposals include regulatory and review process changes, as well as organizational restructuring.

Updates to FDA’s Adverse Events Reporting System (FAERS) Dashboard

Today the U.S. Food and Drug Administration launched a number of improvements to the FDA’s Adverse Event Reporting System (FAERS) dashboard. The FDA is committed to improving the FAERS dashboard and is implementing these changes based on user feedback received since the dashboard was launched in September 2017. The changes encompass a wide-range of items, such as enabling the selection of multiple products for a search and the downloading of search results, as well as enhancing display formats so more information is shown in one screen.

April 23, 2018

FDA Voice - New CDER Report Highlights Ongoing Drug Safety Initiatives and Priorities

Our annual report, Drug Safety Priorities 2017, provides updates on our ongoing initiatives, discusses new work, and highlights last year’s safety-related milestones and achievements.

Just in time for National Drug Take Back Day on Saturday, April 28th check out FDA’s newly revised drug disposal page!

Today the U.S. Food and Drug Administration posted a newly revised drug disposal page. This site contains information for patients and health care providers to help encourage patients to properly get rid of unused, unwanted, or expired prescription medications. Getting rid of these medications is important. When medicines are no longer needed, they should be disposed of promptly, preferably via a drug take-back option, to help reduce the chance that others will accidentally take or intentionally misuse the unneeded medicine.

For more information, please visit drug disposal

March 27, 2018

FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices

The U.S. Food and Drug Administration today permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes. This is the first type of continuous glucose monitoring system permitted by the agency to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management. Today’s authorization also classifies this new type of device in class II and subjects it to certain criteria called special controls. This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible.Read More

March 23, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities

Today, we’re taking a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. Among other things, these provisions limit the bulk drug substances that outsourcing facilities can use in compounding. It directs the FDA to develop a list of bulk drug substances for which there is a clinical need – the 503B bulks list. See more

FDA Updates Purple Book

Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)

February 28, 2018

OPQ Issues Annual Report for 2017

OPQ has published its first public annual report which describes our accomplishments in 2017. OPQ occupies a unique space at the U.S. Food and Drug Administration (FDA) by reaching across all human drug User Fee programs: new drugs and biologics, generics, and biosimilars – and also over-the-counter drugs and compounded drug products. Further, we reach across the drug product lifecycle including development, premarket, and postmarket. Many drugs are currently available to patients and consumers due to OPQ accomplishments across assessment, inspection, surveillance, policy, and research.

Office of Generic Drugs 2017 Annual Report Now Available

Today, the Food and Drug Administration Office of Generic Drugs (OGD) posted their 2017 annual report. In 2017, the FDA approved and tentatively approved 1,027 generic drug applications, the most in the history of the United States Generic Drug program. Generic medicines benefit public health by providing access and more affordable, high quality treatments for patients.

February 5, 2018

Orange Book Annual Edition

FDA posts the annual edition of Approved Drug Products with Therapeutic Ratings, better known as the Orange Book

January 29, 2018

FDA launches a new set of REMS webpages

Today the U.S. Food and Drug Administration (FDA) is launching a new set of webpages that aims to provide a one-stop source for general information about Risk Evaluation and Mitigation Strategy (REMS) programs. These webpages organize general REMS information according to audience (i.e., patients, health care professionals and industry) and most pages are presented in a short question and answer format.

January 19, 2018

2018 Compounding Policy Priorities Plan

The U.S. Food and Drug Administration issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement certain key aspects of the Drug Quality and Security Act (DQSA) and other provisions of the law relevant to compounders. DQSA put in place more robust oversight of compounders and enabled closer federal and state collaboration. It also established a clear legal framework that provides for compounding to meet patients’ medical needs, while also giving the FDA tools to promote the quality of compounded products – which have not undergone FDA premarket review for safety, efficacy and manufacturing controls – and address unlawful compounding practices that threaten public health. Significantly, the law created a new category of compounders, called outsourcing facilities, which may engage in larger-scale, nationwide distribution under additional FDA oversight.

FDA Guidance Documents

January 10, 2018

Advancing Health through Innovation: New Drug Approvals and Other Drug Therapy Advances of 2017 Report

Today, the U. S. Food and Drug Administration released Advancing Health through Innovation: New Drug Therapy Approvals of 2017, a summary of the Center for Drug Evaluation and Research’s (CDER’s) 2017 important new drug approvals that serve to advance public health. These new approvals will benefit patients affected by a wide range of rare diseases, neurological conditions, infectious diseases, cancers, and many other medical conditions.

January 3, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D.

The FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved.More

December 20, 2017

New FDA Drug Safety Communication update on long-acting beta agonists (LABAs)

A U.S. Food and Drug Administration (FDA) review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. In 2011, we required the drug companies that market LABAs to conduct these trials to evaluate the safety of LABAs when used in combination with ICS, and we reviewed the results of these recently completed trials.Read more

What Is Gene Therapy? How Does It Work?

Gene therapy holds the promise to transform medicine and create options for patients who are living with difficult, and even incurable, diseases.

Read this Story

December 15, 2017

FDA updates list of off-patent, off-exclusivity drugs without an approved generic

U.S. Food and Drug Administration (FDA) published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.”

Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).

The list includes approved new drug applications (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. The methodology used to compile the first edition of the list (published June 2017) has been modified to reflect that the list is now based on drug products, not active ingredients. This means that an approved NDA in the active section of FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) for a particular active ingredient and dosage form is included on the list if there are no approved ANDAs for such an NDA, even if there are approved ANDAs that reference a different NDA with the same active ingredient.

FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care

U.S. Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. This approach is intended to aid health care professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria.Read more

November 21, 2017

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse

Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence. Continue reading.

November 9, 2017

FDA Launches One-Hour Free Continuing Education Lecture for Healthcare Providers to Reduce Hypoglycemic Events in Patients with Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) is making available a free, one-hour continuing education (CE) lecture for healthcare providers on Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemic Events in Patients with Type 2 Diabetes.

REMS Integration Initiative

The REMS Integration Initiative was built on stakeholder feedback, and leveraged activities such as public meetings, workshops, listening sessions and a pilot program to ensure comprehensive stakeholder representation. We are very grateful to all those who contributed their time and perspectives to this project. FDA has issued various reports and guidances over the course of this initiative describing what we heard and how we responded. A comprehensive list of work completed can be found on our REMS Integration Initiative website.

October 26, 2017

Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s important efforts to address the opioid crisis

Today the Administration took a historic step to direct additional resources to help address the staggering human and economic toll created by the epidemic of opioid addiction. We thank President Trump for his leadership in further empowering public and private parties around the country to do everything possible to more forcefully address this complex public health crisis. read more

Evaluating the Risk of Drug-Drug Interactions

Talking with Issam Zineh, PharmD, MPH, FCP, FCCP, who is the director of the Office of Clinical Pharmacology, Office of Translational Sciences, CDER.

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NEW Biosimilar Educational Materials for Health Care Professionals - Drug Information Update

FDA is pleased to announce the release of new educational materials for health care professionals about biosimilar and interchangeable products. The agency developed these educational materials to help increase understanding about these important new types of medication among health care professionals.

September 29, 2017

New Director's Corner Podcast: FDA's Adverse Event Reporting System (FAERS)

FDA has released the latest edition of the Director's Corner podcast. Listen to Dr. Woodcock discuss the new FAERS public dashboard tool, which makes FAERS data easier to query and retrieve. She discusses the advantages of the tool as well as its limitations. Click on the following links to read a transcript and listen to the podcast.

FDA Adverse Events Reporting System (FAERS) Public Dashboard

The U.S. Food and Drug Administration launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The new FAERS public dashboard enables users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe.

New report lists compounded drugs produced by FDA-registered outsourcing facilities

For the first time, the FDA is posting a new report that provides a list of the drugs that entities registered as outsourcing facilities have produced. Under the Drug Quality Security Act (DQSA), outsourcing facilities are required to report to the FDA, upon initial registration and each June and December, the drug products that they compounded during the previous six months.

New CDER Conversation: Patents and Exclusivities for Generic Drug Products

The FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the “Orange Book,” includes information about patents or exclusivities that apply to a particular drug product approved under the Federal Food, Drug, and Cosmetic Act (the Act). Patents and exclusivities are two different forms of protection for qualifying drug products that may affect how and when certain generic versions of those drug products are approved.

To read more, please visit: CDER Conversations.

Statement from FDA Commissioner Scott Gottlieb, M.D.

new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities. Read more

September 7, 2017

FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework

FDA Voice Blog

August 31, 2017

New Steps To Strengthen FDA’s Inspection And Oversight Of Drug Manufacturing-Voice Blog

Manufacturing of drugs has become increasingly complex and global, requiring us to remodel our oversight of these tasks, to improve FDA’s efficiency and reach. As a step toward achieving these goals, FDA previously announced that we’re restructuring our field activities, to direct our focus and organization around the programs we regulate, instead of our previous structure, that organized our activities and resources based on geographic regions. This allows us to better align the expertise of our staff and make more efficient use of our resources.

Access Blog

August 21, 2017

Recently Posted Guidance Documents on Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry

Orange Book Updates

Purple Book Update

Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

August 10, 2017

Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft Guidance for Industry

FDA is announcing the availability of a revised draft guidance for industry entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.” The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This revised draft guidance describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration date to assign under those conditions. Through this notice, FDA is hoping to decrease the regulatory burdens of drug regulations on manufacturers of these products, while at the same time ensuring patient safety.

July 7, 2017

FDA Voice Blog

How FDA Plans to Help Consumers Capitalize on Advances in Science

We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions. Over the last few decades, science has enabled fundamental advances in our understanding of the genetic and protein bases of human disease. These developments are already being translated into new medicines. In more cases, these treatments target the underlying mechanisms that drive different diseases. These advances hold out the promise of arresting and even curing a growing number of diseases.

June 30, 2017

Recently Posted Guidance Documents

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry

What’s New for Biologics

Important Recent FDA Actions to Support Generic Drug Development and Access

Today the FDA took two important new steps to encourage generic drug development and increase generic drug access:

These actions are part of Commissioner Gottlieb’s recently announced Drug Competition Action Plan, and follow the announcement of next month’s public meeting on administering the Hatch-Waxman Amendments. The agency plans to take additional, related actions in the near future, and will continue to communicate with stakeholders as these new elements are implemented.

May 31, 2017

Request for comment by July 10, 2017: Training for Opioid Analgesic Prescribers - Exploring the Path Forward

As part of the work by the Federal Government to address the epidemic of prescription and illicit opioid abuse, the FDA is announcing a public workshop to obtain input on issues and challenges associated with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids (safe use of opioids) for health care providers. As discussed in this document, the workshop has three main goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. Finally, participants will be asked about the issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids. More information

CDER SBIA Webinar - Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive - June 15th 2017 - 12:00pm - 3:00pm (Eastern)

This LIVE extended webinar format, with Q&A sessions, is intended to provide a deeper look at REMS, focusing on two topics:

  • REMS - Purpose, Process, and Challenges - An overview of FDA-required REMS for certain high-risk drugs - the purpose they serve in ensuring the benefits of certain drugs outweigh their risks, the process of developing REMS programs, and the unique challenges of the requirement for a single, shared system for generics and brand products.
  • REMS in Structured Product Labeling Format: An Introduction - An introduction to the use of structured product labeling as a format for REMS information. FDA will describe the history of the REMS SPL project, provide an introduction to SPL, and describe the role of REMS SPL in standardizing REMS and integrating them into the healthcare delivery system.

More Information

May 16, 2017

Voice Blog: Reducing Preventable Harm from Medications: Too Big for FDA to Do AloneReducing Preventable Harm from Medications: Too Big for FDA to Do Alone

Reducing preventable harm from medications is a big part of FDA’s mission. It requires teamwork across all of health care and the medication manufacturing, distribution, and delivery system.Reducing preventable harm from medications is a big part of FDA’s mission. It requires teamwork across all of health care and the medication manufacturing, distribution, and delivery system.


April 26, 2017

New FDA Drug Info Rounds Video on Definition of a Drug- Drug Information Update

Watch FDA’s new video, Definition of a Drug video.

Whether a product is regulated as a drug, a cosmetic, or both under the law is determined by a product's intended use. FDA Drug Info Rounds pharmacists discuss the key differences between a drug and a cosmetic.

April 20, 2017

CDER SBIA Chronicles: The Complexities of Compounding

Just over three years ago, Congress amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by enacting the Drug Quality and Security Act (DQSA). The first title of the DQSA, known as the Compounding Quality Act, was passed in response to numerous serious adverse events, including deaths, linked to poor quality compounded drugs. Since enactment of the DQSA, FDA has worked diligently to mitigate the public health risks associated with compounded drugs by conducting inspections and taking appropriate regulatory and enforcement actions, developing policies, convening advisory committee meetings, collaborating and coordinating with the states, and conducting stakeholder outreach.

Audio Podcast

February 28, 2017

2016 Annual Report for the Office of Generic Drugs Now Available2016 Annual Report for the Office of Generic Drugs Now Available

The Food and Drug Administration’s Office of Generic Drugs (OGD) has now posted its 2016 annual report. 2016 marked the highest number of generic drug approvals and tentative approvals ever awarded by OGD–more than 800. These generic drug products have the potential to provide more affordable care to thousands of patients with serious and life-threatening diseases. OGD continues to improve its review infrastructure, meet all Generic Drug User Fee Amendments (GDUFA) commitments, and promote consistency across all applications.

Direct link to the report: https://go.usa.gov/xXqRz

FDA Announces Pharmaceutical Science & Clinical Pharmacology Advisory Committee Meeting March 15, 2017

The Food and Drug Administration will hold a public meeting of the Pharmaceutical Science and Clinical Pharmacology (PSCP) Advisory Committee. The committee will discuss strategies, approaches, and challenges in model-informed drug development for new and generic drugs.

The PSCP Advisory Committee meeting will be held at the Omni Shoreham Hotel, the Ballroom, 2500 Calvert St. NW, Washington, DC 20008 on March 15, 2017, from 7:30am to 3:45pm. The Advisory Committee meeting will be held in conjunction with the American Society for Clinical Pharmacology and Therapeutics 2017 Annual Meeting.

Meeting materials will be available prior to the meeting

New CDER Conversation: Understanding the Influence of Prescription Drug Advertising- Drug Information Update

Talking with Kathryn Aikin, Ph.D., who is a Senior Social Science Analyst and Research Team Lead in the Office of Prescription Drug Promotion, Office of Medical Policy, CDER.

In the past, prescription drug makers typically marketed their drugs only to health care professionals. In the 1980s and early 1990s, companies began to market their products to consumers through direct-to-consumer (DTC) ads, via both print and broadcast media. The Guidance for Industry on Consumer-directed Broadcast Advertisements (finalized in 1999), clarified how a company may fulfill the “adequate provision” obligation for broadcast ads. This obligation stated that, in addition to including important risk information, broadcast ads should describe the sources a consumer can use to find complete prescribing and risk information for the drug.

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January 19, 2017

Healthcare Professional Webinar

DDI Webinar Series: Collaborating with FDA - Get Involved with FDA’s MedWatch Adverse Event Reporting Program

Will be held on: February 7, 2017 Time: 1:00 pm to 2:00 pm (EST)

To register for the online meeting, please visit: https://collaboration.fda.gov/ddi020717/event/registration.html After registering, you will receive a calendar invitation with details on how to join the online meeting.

FDA announces new draft guidances on medical product communication

FDA announced the release of two guidances related to medical product communications and reopened the comment period for the off-label Public Hearing. For more information about this release, please see the Statement from FDA Commissioner Robert Califf, M.D.

The guidances and information on the comment period for the off-label public hearing can be found at:

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers

Medical Product Communications that are Consistent with the FDA-required Labeling – Questions and Answers

Reopening Public Comment Period for Part 15 Hearing on Manufacturer Communications About Unapproved Uses of Approved/Cleared Medical Products

January 12, 2017

January 11, 2017

FDA's Human Drug Compounding Progress Report

FDA issued a document titled, “FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act.”

This report provides a brief overview of the history of drug compounding regulation, as well as FDA’s regulatory oversight of drug compounders, implementation of the compounding provisions of federal law, and state and stakeholder collaboration since enactment of the Drug Quality and Security Act on November 27, 2013. It also discusses the need for ongoing efforts to protect patients from the risks associated with compounded drug products that are not produced in accordance with applicable requirements of federal law, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.

January 12, 2017

Final repackaging guidance and revised draft biologics guidance

Final Guidance: Repackaging of Certain Human Drug Products by State-Licensed Pharmacies and Outsourcing Facilities

Revised Draft Guidance: Mixing, Diluting, and Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

January 5, 2017

2016 Novel Drug Summary

The Food and Drug Administration released a summary of novel drugs approved by the agency’s Center for Drug Evaluation and Research (CDER) in calendar year 2016 as new molecular entities or as new therapeutic biologics. Novel drugs are often innovative products that serve previously unmet medical needs potentially adding significant clinical value to the care of thousands of patients – many with serious and life-threatening diseases. While the quantity of novel drug approvals decreased in 2016, our focus continues to be on the unique medical value of many of these new drugs, their contribution to enhanced patient care, and the various regulatory tools the Agency employed to ensure their safe and efficient development and approval.

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