Xiaoxia Champon

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[FDA Drug Information @FDA_Drug_Info]

FDA is accepting applications until June 30, 2026, for the Rare Disease Endpoint Advancement (RDEA) Pilot Program, which supports novel efficacy endpoint development for drugs that treat rare diseases. Learn more & submit your application today ➡️ https://t.co/SKuZc59RRv

[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Today, the FDA published a draft guidance that when finalized will outline how sponsors can use publicly available information and established platform knowledge to streamline the development of cell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

[U.S. FDA @US_FDA]

FDA is extending the comment period for the Request for Information on Drug Repurposing for Unmet Medical Needs by 30 days — now open until July 11, 2026! https://t.co/HEI7jGG6Km

Plus, join us for a hybrid public workshop on drug repurposing on August 5 that will cover public docket comments & approaches for prioritizing and selecting repurposing candidates. Stay tuned for registration details. https://t.co/RrbxhUjkzn

[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]

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

[FDA Drug Information @FDA_Drug_Info]

FDA has published two guidances that provide recommendations on bioequivalence studies. These guidances will help generate savings by reducing duplicative efforts, regulatory delays, development costs, and process uncertainties for industry. https://t.co/UbGOEV7QSQ

[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

[FDA Drug Information @FDA_Drug_Info]

Today, FDA published 71 new and revised product-specific guidances (PSGs) to accelerate generic drug development and increase competition for conditions such as hypoparathyroidism, myelodysplastic syndromes, and the treatment of opioid use disorder. https://t.co/oaWQlcscdq

[FDA Drug Information @FDA_Drug_Info]

FDA approves Immgolis and Immgolis Intri (golimumab-sldi) as an interchangeable #biosimilar to Simponi and Simponi Aria (golimumab). https://t.co/zKJQ7cYInO

This is the first approval of an interchangeable biosimilar to golimumab.

[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

[U.S. FDA @US_FDA]

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: https://t.co/KNFZCcRPxy

[U.S. FDA @US_FDA]

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. https://t.co/2RFukpHplO

[U.S. FDA @US_FDA]

Last chance to register for the FDA/MHRA/Health Canada Symposium on regulatory perspectives in good clinical practice, bioequivalence, and good pharmacovigilance practice. Secure your spot at this exceptional regulatory learning event.

Join us for:

• Direct insights from FDA, MHRA and Health Canada experts
• Focus on quality culture and innovative trial design
• Real-world case studies from regulatory inspections

Perfect for:

✓ Clinical researchers and trial staff
✓ Regulatory affairs professionals
✓ Pharmaceutical and biotech companies
✓ Research organizations and service providers
✓ Academics and patient advocacy groups

Don't miss this opportunity to learn directly from regulators and experts across the clinical research community.

Register today: https://t.co/uE1ePqjSWu

[U.S. FDA @US_FDA]

What’s really in street drugs? 💊

Dr. Nabarun Dasgupta from @UNC has analyzed 20,000+ samples to try to find out. Join this FDA CERSI-sponsored lecture on the illicit drug supply & overdose trends.

📅 May 7, 3-4 PM ET

Learn More: https://t.co/wmRNTXCxsZ

[U.S. FDA @US_FDA]

Today, the FDA announced two major milestones in implementing real-time clinical trials:

1️⃣ Successful Proofs-of-Concept: FDA unveiled proof-of-concept trials with AstraZeneca and Amgen that report endpoints and data signals in real time.

2️⃣ Pilot Program: The agency released a request for information (RFI) for a broader pilot program launching this summer.

https://t.co/sT5kgbdPBM

[Dr. Marty Makary @DrMakaryFDA]

A milestone day for clinical trial innovation.

We’re announcing the first real-time clinical trials, where @US_FDA can see data signals and endpoints in real time. A quick explainer:

[FDA Drug Information @FDA_Drug_Info]

The CDER Center for Clinical Trial Innovation (C3TI) Compass has been updated. This knowledge repository connects users to FDA guidances, case studies, and practical tools focused on innovative approaches to clinical trial design and conduct. https://t.co/rlPF2lMvKU

[Dr. Marty Makary @DrMakaryFDA]

Awesome to be with 2,500+ kids at @US_FDA’s Bring Your Kid to Work Day. Doesn’t get any better than this!

[U.S. FDA @US_FDA]

Today, the FDA along with @CMSGOV announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway. This collaborative initiative aims to accelerate Medicare coverage for select FDA-designated Class II and Class III medical devices.

https://t.co/QWQo9gKn8F

[FDA Medical Devices @FDADeviceInfo]

The FDA’s AI stance in action!

The agency just cleared an AI ultrasound tool that estimates gestational age in under 2 minutes.

This is the model: support innovation that expands access and improves speed, while holding firm on safety and effectiveness.