FDA Biologics

Latest information from the Center for Biologics Evaluation and Research. Contact us at 1-800-835-4709 or [email protected].

[FDA Drug Information @FDA_Drug_Info]

The FDA has released an updated public report on real-world evidence (RWE) submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) — now including data from Fiscal Year 2025!

[FDA Biologics @FDACBER]

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Today, the FDA published a draft guidance that when finalized will outline how sponsors can use publicly available information and established platform knowledge to streamline the development of cell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

[FDA Drug Information @FDA_Drug_Info]

⏱️REdI 2026 is here!
Don't miss your opportunity to learn from FDA experts across all three medical product centers. Build your regulatory knowledge in drugs, devices, and biologics.
Register and join today ➡️ https://t.co/83o3Co1Kbp

[FDA Drug Information @FDA_Drug_Info]

⏱️REdI 2026 is here!
Don't miss your opportunity to learn from FDA experts across all three medical product centers. Build your regulatory knowledge in drugs, devices, and biologics.
Register and join today ➡️ https://t.co/83o3Co1Kbp

[FDA Drug Information @FDA_Drug_Info]

🕒 There's still time to register!
Secure your spot for the Regulatory Education for Industry Annual Conference 2026. Gain cutting-edge regulatory insights from FDA experts in drugs, devices, and biologics.
📝 Register now—don't miss this opportunity! ➡️ https://t.co/83o3Co1Kbp

[FDA Drug Information @FDA_Drug_Info]

🕒 There's still time to register!
Secure your spot for the Regulatory Education for Industry Annual Conference 2026. Gain cutting-edge regulatory insights from FDA experts in drugs, devices, and biologics.
📝 Register now—don't miss this opportunity! ➡️ https://t.co/83o3Co1Kbp

[FDA Drug Information @FDA_Drug_Info]

🕒 There's still time to register!
Secure your spot for the Regulatory Education for Industry Annual Conference 2026. Gain cutting-edge regulatory insights from FDA experts in drugs, devices, and biologics.
📝 Register now—don't miss this opportunity! ➡️ https://t.co/83o3Co1Kbp

[FDA Drug Information @FDA_Drug_Info]

⏱️REdI 2026 is approaching!
Don't miss your opportunity to learn from FDA experts across all three medical product centers. Build your regulatory knowledge in drugs, devices, and biologics.
🗓️ Mark your calendar and register today ➡️ https://t.co/83o3Co1Kbp

[U.S. FDA @US_FDA]

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: https://t.co/Ya9yRVBK2j

[FDA Drug Information @FDA_Drug_Info]

⏱️REdI 2026 is approaching!
Don't miss your opportunity to learn from FDA experts across all three medical product centers. Build your regulatory knowledge in drugs, devices, and biologics.
🗓️ Mark your calendar and register today ➡️ https://t.co/83o3Co1Kbp

[FDA Biologics @FDACBER]

We will also discuss an update on Baby KJ, whose personalized CRISPR-based gene-editing therapy for a severe urea cycle disorder inspired the Plausible Mechanism Framework, and share researcher experiences on IND clearance and the FDA approval process.

[FDA Biologics @FDACBER]

Join FDA via livestream for a discussion on the plausible mechanism guidance and its applicability to both CDER and CBER products: https://t.co/MP4aQZvVI8

[FDA Biologics @FDACBER]

The program will include special guests Rebecca Ahrens-Nicklas, MD, PhD, University of Pennsylvania, Lindsey A. George, MD, University of Pennsylvania, Kiran Musunuru, MD, PhD, University of Pennsylvania, and Sonia Vallabh, PhD, Broad Institute of MIT and Harvard.

[U.S. FDA @US_FDA]

Today FDA approved the first-ever gene therapy for the treatment of genetic hearing loss under the National Priority Voucher Program.
✅6th approval under the National Priority Voucher Program
✅Approved 61 days after filing

https://t.co/Modecu7S50

[FDA Biologics @FDACBER]

New phenol-free formulation promises field deployment for disease surveillance and vaccine trials, eliminating cold-chain requirements for neglected tropical disease affecting 90+ countries. https://t.co/piSLhsrOKz

[FDA Biologics @FDACBER]

This guidance will provide sponsors with clear, scientifically grounded recommendations to bring effective treatments to patients sooner.

[FDA Biologics @FDACBER]

Today, the FDA issued a draft guidance that when finalized, will provide recommendations for standardized methods for sponsors developing human gene therapy products that incorporate genome editing technologies. https://t.co/JPTNqz1XJj

[FDA Drug Information @FDA_Drug_Info]

⏱️REdI 2026 is approaching!
Don't miss your opportunity to learn from FDA experts across all three medical product centers. Build your regulatory knowledge in drugs, devices, and biologics.
🗓️ Mark your calendar and register today ➡️ https://t.co/83o3Co1Kbp