February 9, 2024

Dear Colleague,

While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.

Updates

• February 7, 2024 - FDA and EMA Launch Parallel Scientific Advice Pilot Program for Complex Generics
• February 6, 2024 - FDA Roundup
• February 5, 2024 - New Guideline Details Acute Pain Management Strategies for Adolescent, Adult Dental Patients
• February 2, 2024 - FDA Roundup

Spotlight!

Meet William R. Carter! A charter member of the FDA, Carter's work with the 1902 “poison squad” was instrumental in establishing government oversight of food and drug safety.

Consumer Updates

FDA-Approved Devices That Help Keep the Heart Beating

Heart disease, also called cardiovascular disease, can have serious consequences. It’s the leading cause of death for adults in the U.S. Medical devices approved by the FDA, such as pacemakers and defibrillators, have extended and improved the lives of millions of people living with heart disease.

Guidance Documents

Conducting Remote Regulatory Assessments Questions and Answers

The FDA or Agency is announcing the availability of a draft guidance for industry entitled “Conducting Remote Regulatory Assessments--Question and Answers.” This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Conducting Remote Regulatory Assessments.”

Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act

The FDA is issuing this guidance to assist registrants of drug establishments in submitting reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(j)(3)), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

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Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

The FDA is announcing the availability of a draft guidance for industry entitled “Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” The draft guidance is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that may, in turn, help the Agency in its efforts to prevent or mitigate shortages.

View all Official FDA Guidance Documents and other Regulatory Guidance
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

ICYMI! Passing the Torch as FDA's Principal Deputy Commissioner

In this video, Janet Woodcock, M.D. and Namandjé Bumpus, Ph.D. talk about passing the torch as FDA's Principal Deputy Commissioner.

Webinars and Virtual Workshops

Expanding Generic Drug Access Through International Engagements

February 28, 2024; 9 - 11:30 AM ET

In this webinar, FDA will discuss and provide updates on FDA and EMA’s Parallel Scientific Advice (PSA) Pilot Program for complex generics/hybrid products, address currently available international engagement opportunities, host a panel discussion on topics pertinent to the generic drug industry, and answer questions during live Q&A sessions with FDA and other global regulatory experts.

Enhancing Adoption of Innovative Clinical Trial Approaches

March 19, 2024, and March 20, 2024; 10:00 AM - 5:00 PM ET

The FDA and the Duke-Margolis Center for Health Policy will convene a hybrid public workshop on March 19 and 20, 2024, to discuss efforts to advance innovation of clinical trial design and conduct. CDER’s portfolio of clinical trial innovation activities are wide ranging and span across drug development programs, therapeutic areas, and scientific disciplines.

FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference

March 20 - 21, 2024

Day1: Wed, Mar 20; 8:00 AM - 5:00 PM ET

Day2: Thu, Mar 21; 8:00 AM - 4:00 PM ET

This two-day conference is intended to share information among FDA representatives, clinical research professionals, and the regulated community, to facilitate the understanding of regulations, guidelines and practices, and to suggest methods and opportunities to enhance the research professional’s product development experience.

View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.