regulatory

Another strong year for novel drug approvals is in the making
Another strong year for novel drug approvals is in the making
EP Vantage
FDA
drug approvals
regulatory
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FDA proposes change to rule on off-label drug use
FDA proposes change to rule on off-label drug use
Stat
FDA
off-label
regulatory
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FDA creates Digital Health Center of Excellence
FDA creates Digital Health Center of Excellence
MedCity News
FDA
digital health
regulatory
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Bristol, Amgen, Teva CEOs among execs to testify at House drug pricing hearings next week
Bristol, Amgen, Teva CEOs among execs to testify at House drug pricing hearings next week
Fierce Pharma
drug pricing
regulatory
Celgene
Bristol-Myers Squibb
Teva Pharmaceutical
Amgen
Novartis
Mallinckrodt
AbbVie
US Congress
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La FDA, c’est moi: In memo, HHS’ Azar asserts power to sign new rules, traditionally purview of agencies’ lawyers
La FDA, c’est moi: In memo, HHS’ Azar asserts power to sign new rules, traditionally purview of agencies’ lawyers
MedCity News
HHS
FDA
Alex Azar
regulatory
COVID-19
pandemic
vaccines
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Has 2020 been a big year for regulatory knockbacks?
Has 2020 been a big year for regulatory knockbacks?
EP Vantage
FDA
regulatory
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PDUFA meeting airs industry's take on FDA communications
PDUFA meeting airs industry's take on FDA communications
RAPS.org
FDA
PDUFA
regulatory
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Trump’s Executive Orders on Drug Pricing: The Drug Channels Guide to Industry Implications
Trump’s Executive Orders on Drug Pricing: The Drug Channels Guide to Industry Implications
Drug Channels
drug pricing
Donald Trump
340B
insulin
regulatory
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FDA kicks off GDUFA III reauthorization process
FDA kicks off GDUFA III reauthorization process
RAPS.org
FDA
generics
regulatory
GDUFA
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FiercePharmaPolitics—States still exploring drug pricing despite congressional gridlock
FiercePharmaPolitics—States still exploring drug pricing despite congressional gridlock
Fierce Pharma
drug pricing
politics
regulatory
legistlation
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FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections
FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections
Fierce Pharma
FDA
regulatory
drug manufacturing
pandemic
COVID-19
regulatory inspections
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Unified agenda: FDA publishes lengthy to-do list
Unified agenda: FDA publishes lengthy to-do list
RAPS.org
FDA
regulatory
devices
de novo pathway
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FiercePharmaPolitics—Grassley's bipartisan drug pricing push in limbo as lawmakers stop negotiating
FiercePharmaPolitics—Grassley's bipartisan drug pricing push in limbo as lawmakers stop negotiating
Fierce Pharma
drug pricing
legistlation
regulatory
Charles Grassley
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Drug lobby sues Minnesota over insulin-pricing law
Drug lobby sues Minnesota over insulin-pricing law
Beckers Hospital Review
Minnesota
regulatory
insulin
drug pricing
diabetes
PhRMA
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How would a Biden White House handle drug prices? Depends on congressional races, analysts say
How would a Biden White House handle drug prices? Depends on congressional races, analysts say
Fierce Pharma
Joe Biden
2020 Presidential election
legislative
regulatory
drug pricing
congress
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As the Coronavirus Spreads, Drug Pricing Legislation Remains Stalled
As the Coronavirus Spreads, Drug Pricing Legislation Remains Stalled
NY Times, NY
drug pricing
regulatory
legislation
pandemic
COVID-19
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Regulators discuss accelerated approvals, Project Orbis at DIA
Regulators discuss accelerated approvals, Project Orbis at DIA
RAPS.org
regulatory
DIA
accelerated approvals
FDA
EMA
Health Canada
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How regulators have adapted globally to clinical trials for drugs and biologics during the COVID-19 crisis
How regulators have adapted globally to clinical trials for drugs and biologics during the COVID-19 crisis
RAPS.org
COVID-19
pandemic
clinical trials
regulatory
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FDA reports on drug quality, oversight trends in FY2019
FDA reports on drug quality, oversight trends in FY2019
RAPS.org
FDA
regulatory
quality
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Canada’s drug price reforms delayed to 2021
Canada’s drug price reforms delayed to 2021
RAPS.org
Canada
regulatory
drug pricing
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