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regulatory
FDA protocol deviation guidance could go further
Clinical Trials Arena
Thu, 01/30/25 - 11:05 am
FDA
clinical trials
regulatory
How might the FDA evolve under RFK Jr. and Makary?
BioSpace
Wed, 01/29/25 - 11:48 am
FDA
HHS
regulatory
Robert F Kennedy Jr.
Marty Makary
Sara Brenner, FDA device official, named agency’s acting head
BioPharma Dive
Mon, 01/27/25 - 11:18 am
FDA
Sara Brenner
Donald Trump
regulatory
The biopharma industry outlook on 2025: Uncertainty and change
BioPharma Dive
Sun, 01/26/25 - 04:16 pm
biotech
JPMHC 2025
China
regulatory
Donald Trump
Navigating FDA’s Draft Guidance for AI-Enabled Medical Devices
Medical Devices and Diagnostics Industry
Thu, 01/23/25 - 11:37 am
Medtech
artificial intelligence
AI-enabled devices
FDA
regulatory
Medtech Implementation of FDA’s Updated QMSR
Medical Devices and Diagnostics Industry
Tue, 01/14/25 - 11:16 am
Medtech
FDA
regulatory
QMSR
5 questions facing pharma in 2025
BioPharma Dive
Fri, 01/10/25 - 11:47 am
Donald Trump
obesity
Novo Nordisk
Eli Lilly
vaccines
pharma stocks
regulatory
immunology
After Drug Rejection, Vanda Blasts ‘Unacceptable’ FDA Conduct in Letter to Commissioner
BioSpace
Thu, 01/9/25 - 11:15 am
Vanda Pharmaceuticals
Robert Califf
regulatory
FDA sets bar for obesity drug development as pipeline swells
First Word Pharma
Tue, 01/7/25 - 06:52 pm
FDA
obesity
regulatory
FDA looks to clarify confirmatory trial mandate for accelerated approvals
Fierce Pharma
Mon, 01/6/25 - 06:51 pm
FDA
regulatory
accelerated approvals
PBMs have evaded lawmakers’ reform attempts so far. Could 2025 turn the tide?
Pharma Voice
Mon, 01/6/25 - 10:46 am
PBMs
regulatory
legislation
4 takeaways from the FDA’s first digital health advisory committee
Medtech Dive
Fri, 12/13/24 - 11:33 am
Medtech
digital health
FDA
regulatory
health equity
artificial intelligence
Pharma, life sciences execs ‘optimistic’ for 2025, eye regulatory concerns
Medical Marketing and Media
Tue, 12/10/24 - 10:07 pm
pharma industry
regulatory
Lilly CEO says tax and regulation reform, drug affordability are focuses under Trump
MSN/Reuters
Tue, 12/10/24 - 09:58 pm
Eli Lilly
David Ricks
Pharma CEOs
Donald Trump
taxes
regulatory
FDA outlines accelerated review guidelines in waning days of Biden administration
BioSpace
Fri, 12/6/24 - 11:23 am
FDA
regulatory
accelerated reviews
COVID-19 critic Marty Makary is Trump’s likely pick for FDA top post
BioSpace
Thu, 11/21/24 - 11:56 am
FDA
regulatory
Marty Makary
Donald Trump
FDA shares additional draft guidance on cell and gene therapy
Clinical Trials Arena
Wed, 11/20/24 - 11:20 am
FDA
regulatory
gene therapy
cell therapy
[podcast]FDA's Foreign Inspections of Drug Manufacturers Have Not Rebounded to Pre-Pandemic Levels
GAO,gov
Wed, 11/13/24 - 09:44 pm
GAO
regulatory
foreign drug inspections
FDA
After election, FDA's Califf lays out hopes for his Trump-appointed successor
Fierce Pharma
Wed, 11/13/24 - 11:22 am
FDA
Robert Califf
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
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