April 26, 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

• April 25, 2024 - Updates on Highly Pathogenic Avian Influenza (HPAI) | FDA
• April 24, 2024 - FDA Approves New Treatment for Uncomplicated Urinary Tract Infections
• April 23, 2024 - FDA Roundup
• April 23, 2024 - FDA Launches Health Care at Home Initiative to Help Advance Health Equity | FDA
• April 22, 2024 - FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication | FDA
• April 19, 2024 - FDA Roundup

FDA Voices

A Milestone in Facilitating the Development of Safe and Effective Biosimilars

By: Sarah Yim, M.D., Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., Chief Medical Officer and Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created a pathway for the U.S. Food and Drug Administration to approve biosimilars. A biosimilar is a biological product (biologic) that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved biologic (also called the reference product). Biologics are some of the most expensive treatments in the U.S., and approving biosimilars can enhance competition, drive down costs to health care systems, and increase patient access to biologic therapies.

Reflections on Travel to Europe – Part Two

By: Robert M. Califf, M.D., Commissioner of Food and Drugs

Our first stop on our recent European trip was London. Although the jet lag on the first day after crossing the Atlantic can be tough and the second day is often more trying, the trip was invigorating and thought provoking. The U.S. Food and Drug Administration’s Office of Global Policy and Strategy and Office of Commissioner staff did a great job arranging a busy schedule that covered multiple critical topics. We had an initial dinner with an eclectic group from the U.K. dealing with policies ranging from women’s health and diversity in clinical trials to the impact of the medical products industry on the economy to pandemic preparedness and response.

Guidance Documents

Cancer Clinical Trial Eligibility Criteria: Laboratory Values

This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants.

Cancer Clinical Trial Eligibility Criteria: Performance Status

This guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status.

Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications

This guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions.

Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry

This revised draft guidance addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products licensed under section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)) and prescription biosimilar products, including interchangeable biosimilar products, licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k)).

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

Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop

May 20 - 21, 2024; 8 a.m. - 4:30 p.m. ET

The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development

May 29 - 30, 2024; 8 a.m. - 4:30 p.m. ET

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.

OTP Town Hall: CMC Readiness for Gene Therapy BLAs

June 4, 2024; 11 a.m. - 12:30 p.m. ET

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Tuesday, June 4, 2024, to answer stakeholder questions regarding the chemistry, manufacturing, and controls (CMC) information submitted with biologics license applications (BLAs) for gene therapy products. Experts from OTP’s Office of Gene Therapy CMC will be on hand to answer questions.

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.