UpdatesMedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe FDA’s medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products. The most recent alerts/recalls are:
Consumer UpdatesFDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Frozen, Raw, Half-shell Oysters from Republic of Korea Potentially Contaminated with NorovirusKhee Trading, Inc. (CA 911 RS) of Compton, CA has recalled frozen half-shell oysters with Lot Code: B250130, harvested from Designated Area No. 1 in the Republic of Korea (ROK) on Jan. 30, 2025, and processed by JBR KR-15-SP in Tongyeong-si, ROK because they may be contaminated with norovirus. The FDA is advising consumers not to eat and restaurants and food retailers not to serve or sell and to dispose of these frozen, raw, half-shell oysters that were shipped to distributors in AZ, CA, CO, GA, ID, KS, NV, TX, UT, and WA, and may have been distributed to other states as well. FDA Direct| FDA Commissioner Marty Makary, M.D., M.P.H. and other members of FDA leadership, as well as guests, engage in timely and frank discussions to bring you an inside look at the current happenings at the FDA. |
Guidance DocumentsView 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!Clinical Trials DayWe celebrate Clinical Trials Day on May 20, in recognition of what is often considered the start of the first randomized clinical trial. In 1747, James Lind began a clinical trial on this day to study the effects of different remedies for scurvy among sailors at sea. His research famously provided evidence of the benefits of citrus fruits to treat this disease. Clinical trials have undergone many changes since the time of James Lind, not only in respect to medical, scientific, and technological advances, but also in terms of ethical and legal requirements. Regardless, clinical trials remain a critical part of drug development, as a means of generating evidence to support the regulatory decision-making for safe and effective new medicines. Webinars and Virtual WorkshopsFDA Expert Panel on Infant Formula
Wed, June 04, 2025; 10 a.m. - noon ET
FDA Commissioner Marty Makary, M.D., M.P.H. will lead a roundtable discussion of an independent panel of scientific experts to discuss infant formula.
Space is limited. Registration is only required for in-person attendance. Please use the link below to register and plan to arrive at least 30 minutes prior to the start time to be checked in. Please use the button below to view via livestream. Fiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop
Tue, June 03, 2025; 8 a.m. - 5:30 p.m. ET
Wed, June 04, 2025; 9 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. View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts About UsThe Public 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, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations. For more information, please contact us at: PublicEngagement@fda.hhs.gov. For patient specific inquiries, please contact us at: Patients Ask FDA. |
