CDER

FDA's drug center to consolidate AI efforts under single council
Fierce Biotech
Thu, 08/29/24 - 06:10 pm
FDA
CDER
regulatory
artificial intelligence
FDA establishes CDER Center for Clinical Trial Innovation
FDA
Mon, 04/15/24 - 09:33 pm
FDA
CDER
clinical trials
clinical trial innovation
This Week at FDA: A glut of guidances
RAPS.org
Sun, 09/10/23 - 07:48 pm
FDA
regulatory
CDRH
CDER
Uptick in FDA adcomms coming in 2023 as CDER hiring picks up, Cavazzoni says
Endpoints
Wed, 04/5/23 - 07:12 pm
FDA
CDER
advisory committees
FDA's Peter Marks backs accelerated approval for gene therapies
BioSpace
Tue, 03/21/23 - 11:36 am
FDA
CDER
Peter Marks
gene therapy
accelerated approval
FDA’s Center for Drug Evaluation and Research approved 37 novel drugs in 2022
Medical Marketing and Media
Tue, 01/10/23 - 06:33 pm
FDA
CDER
drug approvals
CDER proposes withdrawal of approval for Makena
FDA
Sun, 10/9/22 - 05:58 pm
FDA
CDER
Makena
pre-term birth
FDA’s CDER Introduces New ARC Program to Accelerate Rare Disease Cures
Xtalks
Wed, 05/11/22 - 10:41 pm
FDA
CDER
ARC program
Rare Diseases
Is biopharma getting better at accelerated approval conversions?
EP Vantage
Mon, 04/18/22 - 10:37 am
FDA
CDER
accelerated approvals
regulatory
When FDA Makes You An Offer You Can’t Refuse
FDA Law Blog
Wed, 05/26/21 - 12:02 am
FDA
regulatory
drug approvals
CDER
DRG
Cavazzoni paints CDER's post-pandemic future
RAPS.org
Sun, 05/23/21 - 03:20 pm
FDA
CDER
Patrizia Cavazzoni
FDA welcomes alternative approaches to generic drug development
RAPS.org
Wed, 05/5/21 - 09:57 pm
generics
FDA
CDER
drug development
CDER regulatory science division touts 2020 accomplishments
RAPS.org
Mon, 05/3/21 - 10:59 pm
FDA
CDER
regulatory
More FDA Meetings Postponed, Canceled due to Coronavirus
RAPS.org
Wed, 03/18/20 - 11:46 pm
FDA
CDER
COVID-19
Drug approvals: FDA publishes dataset of CDER approvals since 1985
Endpoints
Mon, 02/24/20 - 10:39 am
FDA
CDER
drug approvals
Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal
RAPS.org
Mon, 08/19/19 - 11:38 pm
CDER
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
Overhaul of New Drug Approval Process Moves Forward
Pharma
Sat, 09/29/18 - 12:19 pm
drug approvals
FDA
OND
CDER
Companion diagnostics beyond oncology
Biopharma Dive
Sat, 09/29/18 - 12:01 am
CDER
companion diagnostics
FDA Proposes Process Modernization to Support New Drug Development
FDA Voice
Mon, 06/4/18 - 09:20 am
FDA
CDER
drug development
process modernization

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