February 16, 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 15, 2024 - FDA Issues FY23 Drug Safety Priorities Report
• February 14, 2024 - FDA Approves First Medication to Treat Severe Frostbite
• February 13, 2024 - FDA Roundup
• February 9, 2024 - FDA Roundup

Spotlight!

Meet Icilma Terri Rubin whose crucial behind the scenes work as the FDA's National Health Fraud Coordinator put the agency in a stronger position to respond to health fraud threats and protect consumers from dangerous dietary supplements in the mid-1990s.

Consumer Updates

5 Medication Safety Tips for Older Adults

Whether you’re settling into your 60s or heading into your 90s, be careful when taking medicines, herbal preparations and supplements.

Why the special concern? The older we get, the more likely we are to use more prescription and nonprescription (or over-the-counter, OTC) medicines. That can increase the chance of harmful side effects and drug interactions.

Guidance Documents

Charging for Investigational Drugs Under an IND: Questions and Answers

This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect on October 13, 2009.

Use of Data Monitoring Committees in Clinical Trials

This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB), a data and safety monitoring committee (DSMC), or an independent data monitoring committee (IDMC)) would be useful for trial monitoring and what procedures and practices should be considered to guide their operation.

Advanced Manufacturing Technologies Designation Program

This draft guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program.

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.

Webinars and Virtual Workshops

FDA Oncology Center of Excellence Presents: Conversations on Cancer, Black History Month Program: “Real Talk: Our Stories as Black Oncologists at the FDA”

February 27, 2024; 1 - 2:30 p.m. ET

The FDA Oncology of Excellence (OCE) presents its 6th annual Conversations on Cancer program commemorating Black History Month titled, Real Talk: Our Stories as Black Oncologists at the FDA.

FDA CBER Webinar: Human Gene Therapy Products Incorporating Human Genome Editing

February 29, 2024; 1 - 2 p.m. ET

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public webinar on Thursday, February 29 at 1:00 pm to discuss a recently finalized guidance document on developing human gene therapy products that incorporate human genome editing.

Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice

March 5, 2024; 9 a.m. - 3:30 p.m. ET

The purpose of this public workshop is to facilitate discussion on the use of external data sources, Bayesian statistical methods, and simulations in complex innovative trial designs as well as trial implementation. The meeting will consist of two sessions.

The first session will focus on case studies illustrating various aspects of complex innovative designs and implementation. The second session will consist of panel discussions motivated by the case studies.

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.