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regulatory
Regulatory rejection flurry does not make a storm
EP Vantage
Fri, 10/22/21 - 12:07 pm
FDA
complete response letter
regulatory
Califf re-joining FDA would be positive for industry; analyst
Pharmaforum
Sun, 10/17/21 - 11:02 pm
FDA
Joe Biden
regulatory
Robert Califf
The SEC Wants Badly Behaved Companies to Admit They Did Wrong
Motley Fool
Wed, 10/13/21 - 10:42 pm
SEC
regulatory
FDA’s accelerated approval program: Is change on the way?
RAPS.org
Mon, 10/11/21 - 09:53 pm
FDA
regulatory
accelerated approval
FDA Announces New Process for Requesting Release from Postmarketing Requirements (PMRs)
FDA Law Blog
Fri, 10/8/21 - 10:38 am
regulatory
FDA
post-marketing studies
PDUFA VII
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
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