FDA Updates



Recent Postings from FDA

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.

read more

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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