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regulatory
Inside the FDA’s plans for the largest reorganization in its history
Medical Marketing and Media
Tue, 01/23/24 - 10:55 am
FDA
regulatory
reorganization
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
Congressional watchdog will launch inquiry into FDA oversight of medical device recalls
Medical Marketing and Media
Wed, 01/17/24 - 08:38 pm
GAO
FDA
regulatory
Medtech
device recalls
How FDA’s move on drug importation could shape medical marketing
Medical Marketing and Media
Thu, 01/11/24 - 08:46 pm
FDA
regulatory
drug importation
FDA’s CAR T Probe ‘Not a Big Deal’ for Oncology-Focused Biotechs: Triumvira President
BioSpace
Wed, 01/10/24 - 06:25 pm
oncology
CAR-T
regulatory
FDA
FTC, DOJ finalize guidelines for reviewing anticompetitive mergers
Fierce Healthcare
Wed, 12/20/23 - 09:49 am
FTC
DOJ
antitrust
regulatory
House lawmakers threaten FDA with subpoena amid probe into overseas inspections
Fierce Pharma
Sun, 12/17/23 - 09:55 pm
FDA
regulatory
foreign inspections
FDA Creates Adcomm for Genetic Metabolic Diseases and Potential Treatments
BioSpace
Wed, 12/13/23 - 09:34 am
FDA
advisory committees
genetic metabolic diseases
regulatory
FDA names chief scientist Bumpus as Woodcock’s successor
BioPharma Dive
Wed, 11/29/23 - 12:08 pm
FDA
regulatory
Janet Woodcock
Namandjé Bumpus
FDA's oncology office uses advisory committee to spotlight timely accelerated approval confirmation
Fierce Pharma
Wed, 11/15/23 - 11:20 am
FDA
regulatory
oncology
cancer
accelerated approvals
Acrotech Biopharma
FDA could furlough nearly one-fifth of staff by Sunday
RAPS.org
Thu, 09/28/23 - 11:50 pm
FDA
government shutdown
regulatory
FDA's single-trial guidance calls for the good, bad and ugly data to support effectiveness
Fierce Biotech
Tue, 09/19/23 - 10:23 pm
FDA
clinical trials
regulatory
FDA Finalizes Human Factors Guidance in Combination Medical Devices
Medical Devices and Diagnostics Industry
Wed, 09/13/23 - 11:21 am
Medtech
devices
FDA
regulatory
This Week at FDA: A glut of guidances
RAPS.org
Sun, 09/10/23 - 07:48 pm
FDA
regulatory
CDRH
CDER
FY22 Drug Recalls Highest in Five Years: FDA Report
BioSpace
Thu, 06/22/23 - 10:16 am
FDA
drug manufacturing
product recalls
regulatory
FDA’s workforce goals: tackling recruitment, retention and burnout
Medical Marketing and Media
Mon, 06/5/23 - 09:52 pm
FDA
regulatory
After pandemic delays, FDA still struggling to inspect foreign drug manufacturers
Medical Marketing and Media
Thu, 04/20/23 - 11:49 pm
FDA
regulatory
foreign drug inspections
FDA amends COVID vaccine EUAs, considers animal studies to accelerate updates
RAPS.org
Tue, 04/18/23 - 10:22 pm
FDA
regulatory
COVID-19
vaccines
MRNA
FDA to require new safety warnings for opioids
RAPS.org
Mon, 04/17/23 - 10:50 pm
FDA
regulatory
opioids
opioid crisis
FDA outlines risk-based approach to monitoring clinical trials
RAPS.org
Tue, 04/11/23 - 07:19 pm
clinical trials
regulatory
FDA
risk
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