regulatory

Experts support FDA's plan for restrictions on PD-1 drugs in stomach, esophageal cancers
Fierce Pharma
Thu, 09/26/24 - 06:35 pm
FDA
regulatory
PD-1 inhibitors
stomach cancer
gastric cancer
esophageal cancer
FDA inspection backlog overseas threatens new drug approvals
Pharma Voice
Thu, 09/19/24 - 09:23 am
FDA
regulatory inspections
regulatory
drug approvals
FDA drafts guidance on multiregional clinical trials in oncology
RAPS.org
Mon, 09/16/24 - 10:24 pm
FDA
regulatory
clinical trials
MRCTs
oncology
Balancing innovation and safety: The impact of Medtech regulations
Pharmaphorum
Mon, 09/9/24 - 10:42 am
Medtech
innovation
regulatory
Nearly 2,000 drug manufacturing plants are overdue for FDA inspections after Covid delays
Stat
Thu, 09/5/24 - 11:34 am
regulatory
drug manufacturing
inspections
FDA
FDA adcomm reform talks heat up
Pharma Voice
Tue, 09/3/24 - 11:11 am
FDA
regulatory
adcomm
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 seeks feedback on predetermined change control plans
Medtech Dive
Mon, 08/26/24 - 10:34 pm
FDA
Medtech
PCCPs
regulatory
devices
FDA’s plan to expand device surveillance faces challenges, GAO finds
Medtech Dive
Wed, 08/21/24 - 10:30 pm
FDA
regulatory
GAO
medtehc
devices
Experts fear patient harm from FDA’s lab developed test rule
Medtech Dive
Mon, 08/5/24 - 11:08 pm
Medtech
diagnostics
FDA
regulatory
patients
FDA drug application costs set to rise to $4.3m from October
Clinical Trials Arena
Wed, 07/31/24 - 10:38 am
FDA
regulatory
fees
FDA’s Diversity Action Plan may set a new paradigm for trial transparency
Cl
Tue, 07/30/24 - 11:46 am
FDA
regulatory
clinical trials
clinical trial diversity
A public health call to arms: The long build to FDA’s misinformation guidance
Medical Marketing and Media
Thu, 07/25/24 - 09:58 pm
misinformation
regulatory
FDA
FDA Issues Final Guidance for Using Real-World Data in Drug Applications
BioSpace
Thu, 07/25/24 - 11:24 am
FDA
regulatory
real world data
EHRs
Departing FDA staffers told they can still influence the agency in Big Pharma jobs: BMJ report
Fierce Pharma
Mon, 07/1/24 - 10:05 pm
FDA
regulatory
ethics
lobbying
Supreme Court’s Chevron Doctrine Ruling Could Limit FDA’s Regulatory Authority
BioSpace
Mon, 07/1/24 - 11:27 am
Supreme Court
regulatory
Chevron Doctrine
FDA
FDA reveals diversity action plan guide for clinical trials
Pharmaphorum
Thu, 06/27/24 - 11:14 am
clinical trials
FDA
regulatory
diversity
FTC backs rule change that could expose anticompetitive drug patent deals
First Word Pharma
Tue, 06/18/24 - 08:00 pm
FTC
antitrust
patents
regulatory
FDA repeatedly rejected safety claims made by Philips after the CPAP recall but waited to alert the public, emails show
Medical Marketing and Media
Sun, 02/11/24 - 03:48 pm
Philips
Medtech
FDA
regulatory
recalls
CPAP
FDA finds control lapses at Catalent plant being sold to Novo
Reuters
Tue, 02/6/24 - 11:36 pm
FDA
drug manufacturing
regulatory
Novo Nordisk
Catalent

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