CDER

Uptick in FDA adcomms coming in 2023 as CDER hiring picks up, Cavazzoni says
Uptick in FDA adcomms coming in 2023 as CDER hiring picks up, Cavazzoni says
Endpoints
FDA
CDER
advisory committees
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FDA's Peter Marks backs accelerated approval for gene therapies
FDA's Peter Marks backs accelerated approval for gene therapies
BioSpace
FDA
CDER
Peter Marks
gene therapy
accelerated approval
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FDA’s Center for Drug Evaluation and Research approved 37 novel drugs in 2022
FDA’s Center for Drug Evaluation and Research approved 37 novel drugs in 2022
Medical Marketing and Media
FDA
CDER
drug approvals
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CDER proposes withdrawal of approval for Makena
CDER proposes withdrawal of approval for Makena
FDA
FDA
CDER
Makena
pre-term birth
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FDA’s CDER Introduces New ARC Program to Accelerate Rare Disease Cures
FDA’s CDER Introduces New ARC Program to Accelerate Rare Disease Cures
Xtalks
FDA
CDER
ARC program
Rare Diseases
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Is biopharma getting better at accelerated approval conversions?
Is biopharma getting better at accelerated approval conversions?
EP Vantage
FDA
CDER
accelerated approvals
regulatory
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When FDA Makes You An Offer You Can’t Refuse
When FDA Makes You An Offer You Can’t Refuse
FDA Law Blog
FDA
regulatory
drug approvals
CDER
DRG
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Cavazzoni paints CDER's post-pandemic future
Cavazzoni paints CDER's post-pandemic future
RAPS.org
FDA
CDER
Patrizia Cavazzoni
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FDA welcomes alternative approaches to generic drug development
FDA welcomes alternative approaches to generic drug development
RAPS.org
generics
FDA
CDER
drug development
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CDER regulatory science division touts 2020 accomplishments
CDER regulatory science division touts 2020 accomplishments
RAPS.org
FDA
CDER
regulatory
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More FDA Meetings Postponed, Canceled due to Coronavirus
More FDA Meetings Postponed, Canceled due to Coronavirus
RAPS.org
FDA
CDER
COVID-19
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Drug approvals: FDA publishes dataset of CDER approvals since 1985
Drug approvals: FDA publishes dataset of CDER approvals since 1985
Endpoints
FDA
CDER
drug approvals
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Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal
Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal
RAPS.org
CDER
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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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Overhaul of New Drug Approval Process Moves Forward
Overhaul of New Drug Approval Process Moves Forward
Pharma
drug approvals
FDA
OND
CDER
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Companion diagnostics beyond oncology
Companion diagnostics beyond oncology
Biopharma Dive
CDER
companion diagnostics
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FDA Proposes Process Modernization to Support New Drug Development
FDA Proposes Process Modernization to Support New Drug Development
FDA Voice
FDA
CDER
drug development
process modernization
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CDER in warning letter frenzy as pharma struggles with quality control
CDER in warning letter frenzy as pharma struggles with quality control
Biopharma Dive
CDER
warning letter
quality control
FDA
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Drug Labels: Experts Note Importance of Faster Updates
Drug Labels: Experts Note Importance of Faster Updates
RAPS.org
labeling
FDA
CDER
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Progress and collaboration on clinical trials
Progress and collaboration on clinical trials
Mass Device
FDA
CDER
clinical trials
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