U.S. FDA

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[U.S. FDA @US_FDA]

FDA is committed to advancing Real-World Evidence use in regulatory submissions across product centers & today updated its list of examples of how RWE has informed FDA's regulatory decisions since 2011. CDRH is now included, along with CDER, CBER & OCE. https://t.co/eeKosGIVJi

[FDA Biologics @FDACBER]

Today, the FDA published a draft guidance that when finalized will outline how sponsors can use publicly available information and established platform knowledge to streamline the development of cell and gene therapy products. https://t.co/WWdkcz28Fm

[FDA Biologics @FDACBER]

On Thursday June 4, 2026, from 11 am – 12 PM ET, the Office of Therapeutic Products will host a virtual town hall with experts from OTP’s Office of Review Management & Regulatory Review answering questions regarding Biologic License Application readiness. https://t.co/RsQQHXvdrC

[U.S. FDA @US_FDA]

A reminder to every man: Take time to prioritize your health this month – there is someone counting on you, loving you, and wanting you here for years to come.
#MensHealthMonth #WeCare #FDA

[U.S. FDA @US_FDA]

OTC skin lightening products may contain dangerous mercury and/or hydroquinone, causing serious — even permanent — harm. There are NO FDA-approved OTC options. Talk to your doctor about safe treatments. Learn more: https://t.co/40mIkHeMPt

[U.S. FDA @US_FDA]

Attn: Industry partners — FDA heard you. We're extending the comment period on the Real-Time Clinical Trials Pilot Program Request for Information to June 29. Help shape the future of clinical research. Submit today!

🔗 https://t.co/AUuhLnrAPM

#RealTimeClinicalTrials

[U.S. FDA @US_FDA]

Memorial Day is more than a long weekend. It is a time to remember the heroes who never made it home.

Today, we honor their sacrifice, reflect on the freedoms they fought to protect, and hold close the families who continue to carry their memory forward.

[U.S. FDA @US_FDA]

Today we approved the first-ever FDA-approved treatment for chronic hepatitis delta virus (HDV) infection. For patients living with this serious, life-threatening condition, this approval fills a critical gap in care and offers real hope. https://t.co/cxVUy05ZTk

[U.S. FDA @US_FDA]

FDA has approved Differin Epiduo Acne Gel (adapalene 0.1% + benzoyl peroxide 2.5%) as an over the counter (OTC) acne treatment for people 12 years and older — no prescription needed.

It's the first FDA-approved OTC acne treatment with two active ingredients. 🔗 https://t.co/FnCzU6TSkC

[U.S. FDA @US_FDA]

Today, FDA published 71 new and revised product-specific guidances (PSGs) to improve access to safe, effective, and affordable medications. PSGs facilitate the timely development of high-quality generic drugs by bringing greater efficiency and transparency to the process. https://t.co/DXB1MlaXc2

[U.S. FDA @US_FDA]

The FDA is looking for patients and caregivers to share their experience with CAR T cell therapy during a virtual Patient Listening Session on June 23, 2026. To be considered for the session, fill out this survey TODAY! https://t.co/fbPCxOb0Ro

[U.S. FDA @US_FDA]

Last chance to register for the June 23 Patient Listening Session on CAR T Cell Therapy! ⬇️

[U.S. FDA @US_FDA]

Be heard at the FDA: We’re hosting a virtual Patient Listening Session on CAR T cell therapy on June 23, 2026.

If you are a patient who has received CAR T cell therapy and is interested in sharing your experiences with the FDA, fill out this survey by May 18, 2026. https://t.co/KNFZCcRPxy

#CarTCellTherapy

[U.S. FDA @US_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. https://t.co/HS25ar2jCs

[U.S. FDA @US_FDA]

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.

[U.S. FDA @US_FDA]

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: https://t.co/2RFukpHplO

[U.S. FDA @US_FDA]

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: https://t.co/fbPCxOb0Ro

[Dr. Marty Makary @DrMakaryFDA]

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.

[U.S. FDA @US_FDA]

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. https://t.co/qQPCrOfZwV

[U.S. FDA @US_FDA]

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. https://t.co/ms5ySW3hR7

[FDA Oncology @FDAOncology]

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