CBER

Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.
BioPharma Dive
Thu, 05/8/25 - 11:11 am
FDA
CBER
Vinay Prasad
FDA Commissioner Marty Makary taps Vinay Prasad to head up CBER
Fierce Pharma
Tue, 05/6/25 - 09:30 pm
FDA
Marty Makary
CBER
Vinay Prasad
Deputy director of FDA's CBER departs amid mass exodus at federal health agencies
Fierce Biotech
Sun, 02/23/25 - 10:40 pm
FDA
CBER
Donald Trump
FDA proposes cell and gene therapy site tours to help regulators learn from industry
Fierce Pharma
Mon, 07/15/24 - 11:18 pm
cell therapy
gene therapy
FDA
CBER
OTP
Preventing '3 billion visits' to FDA a year with CBER's Peter Marks
Fierce Biotech
Wed, 05/8/24 - 10:57 pm
FDA
CBER
Peter Markes
ASGCT
FDA’s Marks says CAR-T safety probe ‘probably’ found causal link to lymphoma
Medical Marketing and Media
Fri, 02/16/24 - 11:42 am
CAR-T
FDA
Peter Marks
CBER
FDA’s Marks Advocates for Flexibility in Rare Disease Gene Therapy Trials
BioSpace
Mon, 01/22/24 - 11:01 am
FDA
regulatory
Peter Marks
CBER
clinical trials
gene therapy
FDA’s OTP Super Office on Track to Fill 500 Positions
BioSpace
Thu, 08/10/23 - 09:59 am
FDA
OTP
CBER
Peter Marks
FDA CBER Chief Marks overrules staff drug reviewers 'with trepidation'
Fierce Biotech
Sat, 07/29/23 - 10:50 pm
FDA
Peter Marks
CBER
drug reviews
CBER to Launch Operation Warp Speed for Rare Diseases by Year’s End
BioSpace
Mon, 04/24/23 - 11:36 am
CBER
Operation Warp Speed
FDA
Rare Diseases
CBER director Peter Marks says FDA is growing to keep up with cell and gene therapies
Endpoints
Wed, 03/1/23 - 06:50 pm
CBER
Peter Marks
FDA
gene therapy
cell therapy
FDA elevates OTAT to “Super Office” within CBER
RAPS.org
Mon, 10/3/22 - 10:08 am
regulatory
FDA
OTAT
CBER
PDUFA VII
Convergence: FDA officials on future COVID vaccine updates, remote inspections and hiring
RAPS.org
Wed, 09/14/22 - 08:12 pm
FDA
regulatory
CBER
vaccines
COVID-19
remote inspections
Can FDA replicate Operation Warp Speed for rare diseases? Not yet, but Peter Marks has some ideas
Fierce Biotech
Wed, 05/11/22 - 10:29 am
FDA
Peter Marks
CBER
gene therapy
cell therapy
Operation Warp Speed
Rare Diseases
FDA's Marks takes over vaccines office as agency prepares to part ways with 2 key officials
Fierce Pharma
Tue, 09/28/21 - 11:11 am
FDA
CBER
Peter Marks
vaccines
COVID-19
Gene therapy costs, manufacturing keeping CBER head 'up at night'
Biopharma Dive
Thu, 06/13/19 - 09:47 pm
gene therapy
CBER
drug manufacturing
Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH
RAPS.org
Fri, 04/19/19 - 06:00 pm
FDA
CDER
CBER
CDRH
CBER Director Notes FY 2018 Accomplishments, Including Approval of Two Gene Therapies
BioSpace
Thu, 04/18/19 - 10:14 pm
FDA
CBER
gene therapy
Gottlieb, Marks detail plans to advance development of cell and gene therapies
Endpoints
Wed, 01/16/19 - 10:05 am
FDA
Scott Gottlieb
CBER
cell therapy
gene therapy