U.S. FDA

Each year from May to August, CDC reports Cyclospora case counts. This year FDA, CDC and state partners are working to traceback separate outbreaks simultaneously occurring across the country. One of the best steps you can take to stay healthy is to follow best practices in preparing fruits and vegetables. fda.gov/food/buy-store…

Today, the FDA issued 16 redacted Complete Response Letters (CRLs), underscoring our steadfast commitment to transparency. open.fda.gov/crltable/ Publishing redacted CRLs is one way we continue to ensure that patients, families, clinicians, and innovators all have access to clear, honest information about the FDA decisions that affect them — a cornerstone of the agency's public health mission.

For 120 years, the U.S. Food and Drug Administration has helped protect and promote public health through science, innovation, and oversight. From strengthening the nation’s food supply to advancing safe and effective medical products, the FDA’s work has touched the lives of millions every day since June 30, 1906. Here’s to 120 years of public health—and to the future of scientific and regulatory excellence. Check out our latest FDA Voices Blog post commemorating #FDA120 fda.gov/news-events/fd…

FDA Special Agents/@TheJusticeDept: Alibaba Group and AUS Merchant Services Agree to Pay $600 Million to Resolve Allegations that they Failed to Prevent Illegal Sales of Pharmaceuticals, Pharmaceutical Equipment, and Other Illegal Products justice.gov/opa/pr/alibaba…

The FDA approved an expanded indication for Wilate, a plasma-derived therapy. Previously approved for von Willebrand disease, Wilate is now also approved for patients less than 6 years old with hemophilia A Disease to provide routine prophylaxis to reduce the frequency of bleeding episodes. Wilate is now the only FDA approved von Willebrand Disease product approved for routine prophylaxis for all ages. Find out more: fda.gov/vaccines-blood…

To help women make informed choices about their health, an FDA study has found that U.S. marketed tampons do not pose a health risk from toxic metal exposure. It was conducted after an outside report in 2024 found metals in tampons but didn’t assess harm. Read the results: academic.oup.com/toxsci/article…

Learn how FDA’s Center for Biologics Evaluation and Research (CBER), responsible for regulation of the nation’s blood supply, evaluates Biologics License Applications in its effort to maintain the U.S blood supply: fda.gov/news-events/pu… FDA continues to work with stakeholders on the blood supply chain and will host a roundtable this fall to identify critical gaps and explore strategies to prevent supply chain shortages in equipment, collection systems, solutions and devices used to collect, manufacture, and transfuse blood and blood components. Details will be announced soon.

As we prepare to celebrate America's 250th birthday, National Autism Coordinator Diana Diaz-Harrison and I have an important message for the autism community: stay vigilant around water. Many autistic individuals are naturally drawn to water, and drowning remains a leading cause of death following wandering incidents. Families should be able to celebrate, make memories, and enjoy the holiday safely. By planning ahead and staying alert, we can prevent tragedies and protect our loved ones.

Join us for FDA Grand Rounds on July 9th. FDA’s Human Foods Program will present on an analysis of Shigatoxigenic E. coli prevalence in surface waters, sediment, soil, air and animal feces sampled across the Central Coastal agricultural growing region of California. FDA.gov/GrandRounds

NEWS: @US_FDA’s Center for Veterinary Medicine released a 3-year strategic plan to improve the availability of safe and effective drugs for underserved animal populations. See more: fda.gov/animal-veterin…

By embedding FDA expertise earlier in the facility development process, we're cutting costly delays and giving manufacturers a clearer, more predictable path to market. Learn more: fda.gov/news-events/pr…

FDA has selected 7 companies for the new PreCheck Pilot Program — a first-of-its-kind initiative to strengthen domestic drug manufacturing, boost U.S. supply chain resilience, and help get more affordable medicines to patients faster. #MadeInAmerica

The Navigator was launched as part of our actions to accelerate and modernize early and late-stage clinical development. This new resource is designed to help sponsors prepare and submit Phase 1 IND applications: fda.gov/industry/fda-a…

FDA launched the Phase 1 Investigational New Drug (IND) Navigator, a centralized webpage consolidating tools, guidances, educational resources, and regulatory information from CDER (@FDA_Drug_Info) and @FDACBER. To learn more, visit: fda.gov/industry/phase…

Thank you, @POTUS, for signing this landmark Executive Order to scale regenerative agriculture and advance the Make America Healthy Again agenda. On Thursday, @SecRollins and I joined President Trump alongside America's leading regenerative farmers because healthier food starts with healthier soil. This Executive Order expands support for regenerative agriculture, invests in research to better understand cumulative chemical exposures, and empowers America's farmers to grow a healthier, more abundant, and more affordable food supply. We can't Make America Healthy Again without America's farmers.

Update: The FDA continues to observe unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors. fda.gov/medical-device…

Guys! Listen up! Did you know that men die every day from heart disease that could be prevented? Do something about it before it’s too late. Stop smoking. Eat better. Move around. fda.gov/consumers/heal… #MensHealthMonth #HeartDisease #FDA

Don't let viral myths put your skin health at risk. Visit FDA.gov for trusted sun safety guidance. fda.gov/consumers/cons…

Misinformation about #sunscreen is spreading online — and dermatologists are sounding the alarm. Here's what science actually says: ✅ Routine sunscreen use has NOT been shown to cause vitamin D deficiency ✅ SPF 15+ broad spectrum sunscreens, when used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun ✅Use sunscreen as part of a complete sun safety routine: 🧢 Wear hats, sunglasses & protective clothing 🕙 Limit sun exposure between 10 a.m.–2 p.m. 🔄 Reapply sunscreen every 2 hours (more if swimming or sweating)

This week, FDA, NIH, CMS, ONC, ARPA-H, and the HHS Office of Inspector General launched a coordinated effort to strengthen America's clinical research enterprise and bring more clinical research and investment back to the United States.