@FDACBER profile picture
FDA Biologics @FDACBER
Joined May 2011
  • Tweets 4,812
  • Following 210
  • Followers 23,628
1,248 Photos and videos
FDA Biologics retweeted
FDA Drug Information
@FDA_Drug_Info
Jun 12
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!
2
6
13
3,676
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. fda.gov/vaccines-blood-biolo…
2
2
6
537
Today, the FDA published a draft guidance that when finalized will outline how sponsors can use publicly available information and established platform knowledge to streamline the development of cell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. fda.gov/news-events/press-an…
Grey graphic with text stating "FDA issues draft guidance to streamline development of cell and gene therapy products." The background features multiple faded instances of the words "DRAFT GUIDANCE." The FDA logo is in the bottom right corner.

ALT Grey graphic with text stating "FDA issues draft guidance to streamline development of cell and gene therapy products." The background features multiple faded instances of the words "DRAFT GUIDANCE." The FDA logo is in the bottom right corner.

21
16
63
32,198
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. fda.gov/vaccines-blood-biolo…
A graphic for an OTP Town Hall event by the FDA. The topic is "Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products." Scheduled for Thursday, June 4, 2026, from 11:00 a.m. to 12:00 p.m. ET. The event will be streamed on YouTube, and a recording will be available. The FDA logo is present. No registration is required.

ALT A graphic for an OTP Town Hall event by the FDA. The topic is "Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products." Scheduled for Thursday, June 4, 2026, from 11:00 a.m. to 12:00 p.m. ET. The event will be streamed on YouTube, and a recording will be available. The FDA logo is present. No registration is required.

3
8
11
4,689
FDA Biologics retweeted
FDA Drug Information
@FDA_Drug_Info
May 20
⏱️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 ➡️ fda.gov/news-events/regulato…
Blue promotional graphic for the FDA event "Regulatory Education for Industry (REdI) 2026," hosted by CDER Small Business and Industry Assistance. The event is scheduled for May 19 and 20. The FDA logo appears in the bottom right corner.

ALT Blue promotional graphic for the FDA event "Regulatory Education for Industry (REdI) 2026," hosted by CDER Small Business and Industry Assistance. The event is scheduled for May 19 and 20. The FDA logo appears in the bottom right corner.
1
5
1,672
FDA Biologics retweeted
FDA Drug Information
@FDA_Drug_Info
May 19
⏱️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 ➡️ fda.gov/news-events/regulato…
Blue promotional graphic for the FDA event "Regulatory Education for Industry (REdI) 2026," hosted by CDER Small Business and Industry Assistance. The event is scheduled for May 19 and 20. The FDA logo appears in the bottom right corner.

ALT Blue promotional graphic for the FDA event "Regulatory Education for Industry (REdI) 2026," hosted by CDER Small Business and Industry Assistance. The event is scheduled for May 19 and 20. The FDA logo appears in the bottom right corner.
2
5
1,834
FDA Biologics retweeted
FDA Drug Information
@FDA_Drug_Info
May 19
🕒 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! ➡️ fda.gov/news-events/regulato…
Blue graphic with white text reads: "CDER Small Business and Industry Assistance (SBIA) - Regulatory Education for Industry (REdI) 2026." Below, a calendar icon with "May 19 & 20" is displayed. The bottom features red, white, and blue stars, and an FDA logo.

ALT Blue graphic with white text reads: "CDER Small Business and Industry Assistance (SBIA) - Regulatory Education for Industry (REdI) 2026." Below, a calendar icon with "May 19 & 20" is displayed. The bottom features red, white, and blue stars, and an FDA logo.

1
3
4
2,173
FDA Biologics retweeted
FDA Drug Information
@FDA_Drug_Info
May 18
🕒 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! ➡️ fda.gov/news-events/regulato…
Blue graphic with white text reads: "CDER Small Business and Industry Assistance (SBIA) - Regulatory Education for Industry (REdI) 2026." Below, a calendar icon with "May 19 & 20" is displayed. The bottom features red, white, and blue stars, and an FDA logo.

ALT Blue graphic with white text reads: "CDER Small Business and Industry Assistance (SBIA) - Regulatory Education for Industry (REdI) 2026." Below, a calendar icon with "May 19 & 20" is displayed. The bottom features red, white, and blue stars, and an FDA logo.
4
7
1,976
FDA Biologics retweeted
FDA Drug Information
@FDA_Drug_Info
May 14
🕒 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! ➡️ fda.gov/news-events/regulato…
Blue graphic with white text reads: "CDER Small Business and Industry Assistance (SBIA) - Regulatory Education for Industry (REdI) 2026." Below, a calendar icon with "May 19 & 20" is displayed. The bottom features red, white, and blue stars, and an FDA logo.

ALT Blue graphic with white text reads: "CDER Small Business and Industry Assistance (SBIA) - Regulatory Education for Industry (REdI) 2026." Below, a calendar icon with "May 19 & 20" is displayed. The bottom features red, white, and blue stars, and an FDA logo.
1
6
1,742
FDA Biologics retweeted
FDA Drug Information
@FDA_Drug_Info
May 11
⏱️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 ➡️ fda.gov/news-events/regulato…
Image showing information about the "Regulatory Education for Industry (REdI) 2026" event organized by the FDA’s CDER Small Business and Industry Assistance. Scheduled for May 19 and 20, with a blue background and star graphics.

ALT Image showing information about the "Regulatory Education for Industry (REdI) 2026" event organized by the FDA’s CDER Small Business and Industry Assistance. Scheduled for May 19 and 20, with a blue background and star graphics.

1
1
6
1,537
FDA Biologics retweeted
U.S. FDA
@US_FDA
May 7
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_ls7vA
10
5
31
6,997
FDA Biologics retweeted
FDA Drug Information
@FDA_Drug_Info
Apr 23
⏱️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 ➡️ fda.gov/news-events/regulato…
Image showing information about the "Regulatory Education for Industry (REdI) 2026" event organized by the FDA’s CDER Small Business and Industry Assistance. Scheduled for May 19 and 20, with a blue background and star graphics.

ALT Image showing information about the "Regulatory Education for Industry (REdI) 2026" event organized by the FDA’s CDER Small Business and Industry Assistance. Scheduled for May 19 and 20, with a blue background and star graphics.

2
1
7
2,137
Join FDA via livestream for a discussion on the plausible mechanism guidance and its applicability to both CDER and CBER products: youtube.com/live/1OdI5_ls7vA…
8
6
13
12,366
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.
2
1
556
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.
1
4
448
FDA Biologics retweeted
U.S. FDA
@US_FDA
Apr 23
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 fda.gov/news-events/press-an…
0:14
29
46
205
41,043
New phenol-free formulation promises field deployment for disease surveillance and vaccine trials, eliminating cold-chain requirements for neglected tropical disease affecting 90 countries. sciencedirect.com/science?_o…
2
2
510
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. fda.gov/news-events/press-an…
10
25
72
12,453
This guidance will provide sponsors with clear, scientifically grounded recommendations to bring effective treatments to patients sooner.
1
1
813
FDA Biologics retweeted
FDA Drug Information
@FDA_Drug_Info
Apr 9
⏱️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 ➡️ fda.gov/news-events/regulato…
Image showing information about the "Regulatory Education for Industry (REdI) 2026" event organized by the FDA’s CDER Small Business and Industry Assistance. Scheduled for May 19 and 20, with a blue background and star graphics.

ALT Image showing information about the "Regulatory Education for Industry (REdI) 2026" event organized by the FDA’s CDER Small Business and Industry Assistance. Scheduled for May 19 and 20, with a blue background and star graphics.

3
4
9
1,971
Load more