CBER

CBER to Launch Operation Warp Speed for Rare Diseases by Year’s End
CBER to Launch Operation Warp Speed for Rare Diseases by Year’s End
BioSpace
CBER
Operation Warp Speed
FDA
Rare Diseases
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CBER director Peter Marks says FDA is growing to keep up with cell and gene therapies
CBER director Peter Marks says FDA is growing to keep up with cell and gene therapies
Endpoints
CBER
Peter Marks
FDA
gene therapy
cell therapy
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FDA elevates OTAT to “Super Office” within CBER
FDA elevates OTAT to “Super Office” within CBER
RAPS.org
regulatory
FDA
OTAT
CBER
PDUFA VII
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Convergence: FDA officials on future COVID vaccine updates, remote inspections and hiring
Convergence: FDA officials on future COVID vaccine updates, remote inspections and hiring
RAPS.org
FDA
regulatory
CBER
vaccines
COVID-19
remote inspections
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Can FDA replicate Operation Warp Speed for rare diseases? Not yet, but Peter Marks has some ideas
Can FDA replicate Operation Warp Speed for rare diseases? Not yet, but Peter Marks has some ideas
Fierce Biotech
FDA
Peter Marks
CBER
gene therapy
cell therapy
Operation Warp Speed
Rare Diseases
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FDA's Marks takes over vaccines office as agency prepares to part ways with 2 key officials
FDA's Marks takes over vaccines office as agency prepares to part ways with 2 key officials
Fierce Pharma
FDA
CBER
Peter Marks
vaccines
COVID-19
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Gene therapy costs, manufacturing keeping CBER head 'up at night'
Gene therapy costs, manufacturing keeping CBER head 'up at night'
Biopharma Dive
gene therapy
CBER
drug manufacturing
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Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH
Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH
RAPS.org
FDA
CDER
CBER
CDRH
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CBER Director Notes FY 2018 Accomplishments, Including Approval of Two Gene Therapies
CBER Director Notes FY 2018 Accomplishments, Including Approval of Two Gene Therapies
BioSpace
FDA
CBER
gene therapy
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Gottlieb, Marks detail plans to advance development of cell and gene therapies
Gottlieb, Marks detail plans to advance development of cell and gene therapies
Endpoints
FDA
Scott Gottlieb
CBER
cell therapy
gene therapy
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