regulatory

‘Slippery slope territory’: Health officials propose waiving regulatory review of medical AI tools
‘Slippery slope territory’: Health officials propose waiving regulatory review of medical AI tools
Stat
regulatory
artificial intelligence
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PBM lobby sues to block HHS rule denying PBMs drugmaker rebates
PBM lobby sues to block HHS rule denying PBMs drugmaker rebates
Beckers Hospital Review
PBMs
regulatory
HHS
discounts
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FDA’s top lawyer resigns, agency veteran takes acting role
FDA’s top lawyer resigns, agency veteran takes acting role
RAPS.org
FDA
regulatory
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'N of 1' therapies addressed in draft FDA guidance
'N of 1' therapies addressed in draft FDA guidance
RAPS.org
FDA
regulatory
N of 1
individualized medicine
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Judge blocks Trump's 'most favored nation' drug pricing rule
Judge blocks Trump's 'most favored nation' drug pricing rule
Fierce Pharma
drug pricing
regulatory
most favored nation
Donald Trump
Medicare
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Judge blocks Trump's 'most favored nation' drug pricing rule
Judge blocks Trump's 'most favored nation' drug pricing rule
Beckers Hospital Review
drug pricing
most favored nation
Donald Trump
regulatory
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FDA ends Unapproved Drugs Initiative
FDA ends Unapproved Drugs Initiative
Beckers Hospital Review
FDA
regulatory
Unapproved Drugs Initiative
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Canada blocks bulk exports of some prescription drugs in response to Trump import plan
Canada blocks bulk exports of some prescription drugs in response to Trump import plan
Reuters
Canada
exports
Donald Trump
regulatory
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Trump Administration Slaps Pharma Industry with International Reference Pricing Rule (But will it Survive?)
Trump Administration Slaps Pharma Industry with International Reference Pricing Rule (But will it Survive?)
FDA Law Blog
regulatory
drug pricing
Donald Trump
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With only weeks left in his presidency, Trump makes a final, long-shot bid to remake US drug pricing
With only weeks left in his presidency, Trump makes a final, long-shot bid to remake US drug pricing
Endpoints
drug pricing
Donald Trump
regulatory
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In 2 years, insurers must disclose what they pay for prescription drugs
In 2 years, insurers must disclose what they pay for prescription drugs
Beckers Hospital Review
regulatory
insurers
reimbursement
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A big week for mRNA COVID-19 vaccines: Five key developments
A big week for mRNA COVID-19 vaccines: Five key developments
Biopharma Reporter
vaccines
COVID-19
Moderna Therapeutics
Pfizer
BioNTech
MRNA
logistics
regulatory
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CEO of biotech group says lawsuits are on the table to stop Trump drug proposal
CEO of biotech group says lawsuits are on the table to stop Trump drug proposal
The Hill
drug pricing
Donald Trump
regulatory
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Senate committee proposes $3.2B budget for FDA
Senate committee proposes $3.2B budget for FDA
RAPS.org
FDA
Senate
regulatory
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FDA staff resist executive order amid fears Trump could reshape agency: report
FDA staff resist executive order amid fears Trump could reshape agency: report
Fierce Biotech
FDA
Donald Trump
regulatory
2020 Presidential election
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Survey: A third of states weighing moves to spend less on drugs
Survey: A third of states weighing moves to spend less on drugs
MedCity News
drug pricing
regulatory
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Testing requirements are likely slowing biosimilar entries in the US
Testing requirements are likely slowing biosimilar entries in the US
RAPS.org
biosimilars
regulatory
patents
drug rebates
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Thinking the unthinkable on Covid vaccine approvals
Thinking the unthinkable on Covid vaccine approvals
EP Vantage
COVID-19
pandemic
regulatory
FDA
EMA
Europe
vaccines
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5 Hot Trends in Wearable Medical Devices
5 Hot Trends in Wearable Medical Devices
Medical Devices and Diagnostics Industry
devices
wearables
regulatory
FDA
wellness
COVID-19
pandemic
funding
digital health
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Generic drugmakers get guidance on tentative approvals, CRLs
Generic drugmakers get guidance on tentative approvals, CRLs
RAPS.org
FDA
regulatory
generics
ANDAs
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