regulatory

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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EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
RAPS.org
EMA
Europe
regulatory
clinical trial transparency
COVID-19
pandemic
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FDA explains impact of COVID-19 on applications, formal meetings
FDA explains impact of COVID-19 on applications, formal meetings
RAPS.org
FDA
regulatory
pandemic
COVID-19
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New Developments in FDA Regulation of AI
New Developments in FDA Regulation of AI
Medical Devices and Diagnostics Industry
FDA
artificial intelligence
regulatory
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Ex-FDA chief says regulator needs to up pace on COVID-19 drugs
Ex-FDA chief says regulator needs to up pace on COVID-19 drugs
Fierce Biotech
Scott Gottlieb
FDA
regulatory
COVID-19
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Trump administration uses wartime powers to be first in line on medical supplies
Trump administration uses wartime powers to be first in line on medical supplies
MedCity News
Donald Trump
regulatory
medical supplies
COVID-19
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Coronavirus Relief Bill Includes OTC Drug User Fee Program
Coronavirus Relief Bill Includes OTC Drug User Fee Program
RAPS.org
COVID-19
OTC
user fees
drug shortages
legislation
regulatory
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Go or no go? Covid-19 upstages US regulatory decisions
Go or no go? Covid-19 upstages US regulatory decisions
EP Vantage
FDA
regulatory
Bristol-Myers Squibb
ozanimod
Esteve
E-58425
Fabre-Kramer
AstraZeneca
Imfinzi
Astellas
Vesicare
AbbVie
Neurocrine
Orlissa
Sanofi
MenQuadfi
opicapone
Acceleron
Reblozyl
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FDA to Implement All COVID-19-Related Guidance Immediately, Without Public Comment
FDA to Implement All COVID-19-Related Guidance Immediately, Without Public Comment
RAPS.org
FDA
COVID-19
regulatory
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Will COVID-19 Derail New Drugs?
Will COVID-19 Derail New Drugs?
Motley Fool
COVID-19
SEC
regulatory
clinical trials
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Bayer and MassBio teach startups regulatory ins and outs at new center
Bayer and MassBio teach startups regulatory ins and outs at new center
Fierce Pharma
regulatory
Bayer
MassBio
startups
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Georgia bill seeks lower drug prices by focusing on middlemen
Georgia bill seeks lower drug prices by focusing on middlemen
Atlanta Journal Constitution, GA
drug pricing
PBMs
Georgia
legislation
regulatory
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Government spending bill tweak means 3 more NDAs will become BLAs, FDA says
Government spending bill tweak means 3 more NDAs will become BLAs, FDA says
Endpoints
legislation
regulatory
biologics
NDAs
BLAs
FDA
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Washington took a decade to approve an obscure drug-pricing bill. That’s a bad omen for more ambitious reforms
Washington took a decade to approve an obscure drug-pricing bill. That’s a bad omen for more ambitious reforms
Stat
drug pricing
regulatory
legislation
Donald Trump
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