regulatory

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FDA shares additional draft guidance on cell and gene therapy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
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

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