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Postings from FDA 2016

December 20, 2016

New Director's Corner Podcast - Drug Information Update

Listen to Dr. Woodcock discuss the FDA's actions to implement the Opioid Action Plan, including important safety labeling changes.

December 8, 2016

Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry

The portion of this guidance that describes when manufacturers should notify FDA if there is a high risk that a product is illegitimate, is being distributed for comment purposes only.

Drug Shortages Infographic

The FDA recently published an infographic on drug shortages

November 29, 2016

Prescription to Over-the-Counter (OTC) Switch List (Updated)

November 23, 2016

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

November 18, 2016

FDA Publishes Orange Book Cumulative Supplement

November 10, 2016

Ninth Annual Sentinel Initiative Public Workshop- Drug Information Update

The Food and Drug Administration (FDA) is announcing a public workshop to be held on February 2, 2017, entitled “Ninth Annual Sentinel Initiative Public Workshop.” Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with the FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance.

Registration Information

October 25, 2016

The FDA Launches New Webpage for Reporting Allegations of Regulatory Misconduct

An allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law. Reporting these allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise. This information can help the FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as any steps needed to address or correct a potential violation.

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FDA’s Opioids Action Plan: A Midyear Checkup

As FDA works to address the opioid epidemic of abuse, misuse and addiction, it’s valuable to see firsthand some of the ways the crisis is affecting our communities.

See Blog Post

October 17, 2016

[Compounding Proposed Rule]: Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness

The FDA has proposed a rule that would amend the list of drug products that may not be compounded under certain sections of the Food, Drug, and Cosmetic that provide for marketing of compounded drugs because they have been withdrawn or removed from the market for safety or effectiveness reasons. The proposed rule is open for comment for 75 days.

The public comment period for the proposed rule will be open for 75 days. For information on how to submit comments to the public docket, see the notice in the Federal Register.

Please see the statement FDA's website for more information.

September 29, 2016

Upcoming FDA Workshops

Nov. 18, 2016: FDA-Johns Hopkins CERSI Co-sponsored Workshop on Substitutability of Generic Drugs: Perceptions and Reality

This workshop will:

  • Discuss current progress on generic drug surveillance method development, generic substitution study outcomes, and surveys about generic drugs
  • Build confidence in generic drugs by demonstrating FDA’s commitment to monitoring generic drugs in the postmarket setting and presenting evidence to confirm equivalency
  • Provide timely communication of the results of postmarket research related to generic drugs
  • Identify future research needs in postmarket surveillance of generic drugs.

September 12, 2016

FDA Updates Guidance Agenda

FDA has published an updated list of guidance documents it intends to publish by the end of the current year. The LTC pharmacy industry is waiting for the updated guidance titled Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
September 2, 2016

FDA Basics Webinar "FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA"-

Did you know that you can report problems that you have had with drugs and other medical products to the FDA? Did you know that MedWatch can send safety alerts directly to you, as soon as they appear on the web site? The featured speaker, Cristina Whalen Klafehn PharmD, BCPS, CDE, a Health Programs Coordinator in FDA’s Office of Health and Constituent Affairs will give an overview of the program, including recent updates, on the reporting of adverse events to the FDA.

For more information and program slides, please visit: FDA Basics Webinar.

September 1, 2016

FDA MedWatch - Drug Safety Labeling Changes (SLC) Program now available in new, user-friendly format

FDA announces safety labeling change (SLC) data on the Web will now be available in real time for health care providers, health information technology vendors, and the public to view, search, and download. Ultimately, the FDA expects that prompt access to these vital safety data by health care providers and consumers will better promote patient health.

The FDA MedWatch program posted safety labeling changes monthly to the FDA MedWatch web site and sent an email link to all subscribers of the MedWatch email list by the 15th of the month. The Drug Safety Labeling Changes (SLC) database provides approved safety labeling changes from January 2016 forward. Data prior to July 2016 will continue to be available on the MedWatch website

Please visit the database to obtain the most recent label changes:

August 15, 2016

Redesigned Orange Book improves design and functionality

The U.S. Food and Drug Administration (FDA) today launched an improved web-based version of the Approved Drug Products with Therapeutic Equivalence Evaluations – most commonly known as the “Orange Book.” This is the first major revision of the web page and features an updated design with new, user-friendly search options that help users customize their research experience.

The redesigned Orange Book web page conveniently collects search and browse options onto the home page to improve access of these commonly used features. Groups of “accordion” panels open to reveal new and enhanced features and contact information.

The Orange Book, which identifies drug products approved on the basis of safety and effectiveness by the FDA, first appeared as a published list in October 1980. Since 1984, the Orange Book has also included information about patents and exclusivity for listed products. In 1997, the FDA made the Orange Book database available for searching on the Web. Today, “Orange Book” is one of the most searched-for terms on FDA.gov.

August 3, 2016

Pharmacy Compounding: Draft insanitary conditions guidance available for comment

The FDA issued draft guidance on insanitary conditions at compounding facilities. The draft guidance is intended to assist compounding facilities in identifying insanitary conditions so they can implement appropriate corrective actions. It is also intended to assist state regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions.

The FDA also posted a statement on the draft guidance.

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