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regulatory
Generic drugmakers get guidance on tentative approvals, CRLs
RAPS.org
Mon, 09/28/20 - 10:29 pm
FDA
regulatory
generics
ANDAs
Another strong year for novel drug approvals is in the making
EP Vantage
Fri, 09/25/20 - 10:50 am
FDA
drug approvals
regulatory
FDA proposes change to rule on off-label drug use
Stat
Wed, 09/23/20 - 11:46 pm
FDA
off-label
regulatory
FDA creates Digital Health Center of Excellence
MedCity News
Wed, 09/23/20 - 11:18 pm
FDA
digital health
regulatory
Bristol, Amgen, Teva CEOs among execs to testify at House drug pricing hearings next week
Fierce Pharma
Tue, 09/22/20 - 10:21 pm
drug pricing
regulatory
Celgene
Bristol-Myers Squibb
Teva Pharmaceutical
Amgen
Novartis
Mallinckrodt
AbbVie
US Congress
La FDA, c’est moi: In memo, HHS’ Azar asserts power to sign new rules, traditionally purview of agencies’ lawyers
MedCity News
Tue, 09/22/20 - 10:52 am
HHS
FDA
Alex Azar
regulatory
COVID-19
pandemic
vaccines
Has 2020 been a big year for regulatory knockbacks?
EP Vantage
Thu, 09/17/20 - 10:37 am
FDA
regulatory
PDUFA meeting airs industry's take on FDA communications
RAPS.org
Wed, 08/19/20 - 09:29 am
FDA
PDUFA
regulatory
Trump’s Executive Orders on Drug Pricing: The Drug Channels Guide to Industry Implications
Drug Channels
Sun, 07/26/20 - 11:13 pm
drug pricing
Donald Trump
340B
insulin
regulatory
FDA kicks off GDUFA III reauthorization process
RAPS.org
Wed, 07/22/20 - 12:00 am
FDA
generics
regulatory
GDUFA
FiercePharmaPolitics—States still exploring drug pricing despite congressional gridlock
Fierce Pharma
Mon, 07/20/20 - 11:11 am
drug pricing
politics
regulatory
legistlation
FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections
Fierce Pharma
Mon, 07/13/20 - 11:27 pm
FDA
regulatory
drug manufacturing
pandemic
COVID-19
regulatory inspections
Unified agenda: FDA publishes lengthy to-do list
RAPS.org
Wed, 07/8/20 - 11:49 pm
FDA
regulatory
devices
de novo pathway
FiercePharmaPolitics—Grassley's bipartisan drug pricing push in limbo as lawmakers stop negotiating
Fierce Pharma
Mon, 07/6/20 - 11:04 am
drug pricing
legistlation
regulatory
Charles Grassley
Drug lobby sues Minnesota over insulin-pricing law
Beckers Hospital Review
Thu, 07/2/20 - 11:07 am
Minnesota
regulatory
insulin
drug pricing
diabetes
PhRMA
How would a Biden White House handle drug prices? Depends on congressional races, analysts say
Fierce Pharma
Mon, 06/29/20 - 06:25 pm
Joe Biden
2020 Presidential election
legislative
regulatory
drug pricing
congress
As the Coronavirus Spreads, Drug Pricing Legislation Remains Stalled
NY Times, NY
Mon, 06/29/20 - 06:18 pm
drug pricing
regulatory
legislation
pandemic
COVID-19
Regulators discuss accelerated approvals, Project Orbis at DIA
RAPS.org
Wed, 06/17/20 - 10:46 am
regulatory
DIA
accelerated approvals
FDA
EMA
Health Canada
How regulators have adapted globally to clinical trials for drugs and biologics during the COVID-19 crisis
RAPS.org
Mon, 06/15/20 - 11:02 pm
COVID-19
pandemic
clinical trials
regulatory
FDA reports on drug quality, oversight trends in FY2019
RAPS.org
Wed, 06/10/20 - 10:36 am
FDA
regulatory
quality
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