U.S. FDA

As National Women's Health Week comes to an end, we encourage you to share your treatment experiences on CURE ID - from Long COVID to pregnancy complications. Your real-world data helps fill gaps in women's health research. cure.ncats.io/home

FDA is committed to protecting the health and safety of women. The Supreme Court’s order, issued today, maintains the status quo with respect to the REMS governing mifepristone. The FDA will press forward to complete its science-based safety review of the mifepristone REMS and, in an effort to provide greater transparency, will provide updates as key milestones are reached.

Happening Tomorrow! FDA will be taking industry questions on a proposed pilot program to assess how AI-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials. Register here: fda.gov/news-events/fd…

Have you developed secondary malignancies after CAR T cell therapy? The FDA is hosting a virtual Patient Listening Session for patients and caregivers to share their experience. Fill out this survey by May 18, 2026: qualtricsxmjqffz4ktl.qualtrics.com/jfe/form/SV_09…

Pregnant women shouldn't be left guessing about how approved drugs could affect their pregnancy. Our new FDA guidance is designed to help close that information gap.

FDA is calling on patients, clinicians, and researchers to help identify drugs that could be repurposed to treat chronic and rare diseases and help address other unmet medical needs. Share your ideas to help advance new treatment options. fda.gov/news-events/pr…

As we close out #PublicServiceRecognitionWeek, we celebrate the FDA drug safety champions who are not just protecting Americans today but building the medicine of tomorrow. ✅ Eliminating unnecessary animal testing ✅ Advancing real-time clinical trials ✅ Accelerating approvals through the Commissioner’s new National Priority Voucher Program Smarter science. Safer drugs. That's FDA. fda.gov/drugs

#FDA grants seventh approval under the National Priority Voucher pilot program.

New guidance: “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.” It describes enforcement policies regarding marketing of certain ENDS and nicotine pouch products that don’t have premarket authorization. fda.gov/tobacco-produc…

The FDA is helping improve how safety data is collected for drugs & biologics used during pregnancy. Pregnant patients & their providers deserve clear, reliable information to make informed treatment decisions — and this final guidance is a step in the right direction. fda.gov/news-events/pr…

Have you received CAR T cell therapy or cared for a child under 18 who received the therapy? Share your experience with FDA staff during a virtual Patient Listening Session on June 23, 2026. To be considered for the session, fill out this survey by May 18, 2026: qualtricsxmjqffz4ktl.qualtrics.com/jfe/form/SV_09…

What's on your plate matters — and FDA is making sure it's safer and healthier than ever. ✅ Modernizing infant formula safety ✅ Rewriting dietary guidelines ✅ Removing artificial food dyes ✅ Fighting chronic illness through REAL FOOD FDA's food safety champions are building a healthier America — one policy at a time. fda.gov/food #PSRW

This week, @FDACBER and @FDA_Drug_Info held an all-hands discussion on FDA's Plausible Mechanism Framework, featuring expert guests from @Penn and @broadinstitute. Topics included an update on Baby KJ, whose personalized CRISPR therapy inspired the framework, and researcher experiences with the IND & approval process. Watch the recording here: youtube.com/live/1OdI5_ls7…

A big improvement to FDA’s inspection toolkit.

From FDA headquarters to field offices around the world, thousands of FDA employees collaborate every day to keep your food safe, your medicine effective, your medical products reliable and your cosmetics trustworthy. At FDA teamwork isn't just a value — it's how we protect America. fda.gov/about-fda/fda-… #PSRW

The FDA will be taking industry questions on a proposed pilot program to assess how AI-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials. fda.gov/news-events/fd…

FDA scientists are among the best in the world. Now they have the tools to match. With our new AI upgrades and unified data platform, our reviewers spend less time on paperwork and more time on the science that gets safe, effective treatments to you faster. fda.gov/news-events/pr…

“Why do 1-in-10 American kids have a peanut or food allergy when hardly anyone had a peanut or food allergy just one generation ago?” At this year’s inaugural @HHSGov National Conference on Women’s Health, @DrMakaryFDA explored how shifts in the microbiome—and long-held medical assumptions—may be contributing to this rise.

FDA inspectors & investigators are the frontline champions of public safety. Did you know that each year, OII employees travel over 26 million miles to conduct FDA operations in the U.S. and abroad? Every warning letter, every product recall, every import refusal stops an unsafe product at the border. It starts with them. fda.gov/about-fda/fda-…