regulatory

Biden closes in on pick to lead Food and Drug Administration
Politico
Thu, 10/7/21 - 11:10 am
FDA
regulatory
Joe Biden
Laurie Glimcher
With D.C. drug pricing negotiations still up in the air, the 'endgame' could still 'have a bite,' analyst says
Fierce Pharma
Wed, 10/6/21 - 11:00 am
drug pricing
legislation
regulatory
FDA center directors on lessons from the EUA pathway: Flexibility serves us well
Endpoints
Wed, 10/6/21 - 10:50 am
FDA
regulatory
Emergency Use Authorizations
Teva temporarily padlocks a plant after FDA cites it for contamination
Endpoints
Tue, 10/5/21 - 09:35 pm
FDA
Teva Pharmaceutical
drug manufacturing
regulatory
FDA resists industry push to nix De Novo inspections in final rule
Medtech Dive
Tue, 10/5/21 - 10:47 am
FDA
regulatory
de novo pathway
devices
Medtech
11 FDA Plans You Need to Know About
Medical Devices and Diagnostics Industry
Thu, 09/30/21 - 10:50 am
FDA
devices
Medtech
regulatory
The FDA Has Been Without A Permanent Leader For 8 Months, As COVID Cases Climb
NPR
Wed, 09/22/21 - 11:04 am
Joe Biden
FDA
regulatory
pandemic
COVID-19
Scott Gottlieb: Trump’s shadow FDA commissioner during Covid-19?
Stat
Tue, 09/21/21 - 10:53 am
FDA
COVID-19
Scott Gottlieb
regulatory
Donald Trump
FDA finalizes more Q&As on biosimilar development
RAPS.org
Mon, 09/20/21 - 11:03 pm
FDA
regulatory
biosimilars
drug development
FDA continues data modernization with new Office of Digital Transformation
RAPS.org
Fri, 09/17/21 - 10:56 am
FDA
data modernization
regulatory
digital pharma
Global healthcare regulatory workforce nearly 100K, says new report from RAPS, Elemed
RAPS.org
Wed, 09/15/21 - 10:11 pm
regulatory
PDUFA VII is a step in the right direction for the rare disease community
RAPS.org
Tue, 09/7/21 - 10:51 pm
FDA
regulatory
PDUFA VII
Rare Diseases
What to expect at the FDA's two-day meeting on gene therapy safety
BioPharma Dive
Wed, 09/1/21 - 01:32 pm
FDA
regulatory
gene therapy
Clinical trial site remote monitoring may suffice: Updated FDA guidance
RAPS.org
Tue, 08/31/21 - 10:09 pm
clinical trials
remote clinical trials
pandemic
COVID-19
regulatory
FDA
Industry lauds PDUFA VII focus on innovation, transparency
RAPS.org
Thu, 08/26/21 - 08:46 pm
PDUFA VII
innovation
regulatory
transparency
FDA
Top 7 challenges facing the medical device market
MedCity News
Wed, 08/25/21 - 11:13 am
devices
Medtech
supply chain
regulatory
cybersecurity
intellectual property
device recalls
legal
competition
PDUVA VII commitment letter: RWE, rare diseases see renewed attention
RAPS.org
Mon, 08/23/21 - 11:20 pm
FDA
regulatory
PDUFA VII
RWE
real world evidence
Biden said to rule out Woodcock as permanent FDA chief
BioPharma Dive
Fri, 08/20/21 - 12:37 pm
FDA
Janet Woodcock
regulatory
Joe Biden
The 6-Year Saga Finally Ends: FDA Issues Final Rule Modifying The Intended Use Regulation
FDA Law Blog
Sun, 08/15/21 - 11:10 pm
FDA
intended use
regulatory
FDA new drug applications to cost more than $3M in 2022
Beckers Hospital Review
Sat, 08/14/21 - 01:53 pm
FDA
NDAs
regulatory

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