regulatory

After pandemic delays, FDA still struggling to inspect foreign drug manufacturers
After pandemic delays, FDA still struggling to inspect foreign drug manufacturers
Medical Marketing and Media
FDA
regulatory
foreign drug inspections
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FDA amends COVID vaccine EUAs, considers animal studies to accelerate updates
FDA amends COVID vaccine EUAs, considers animal studies to accelerate updates
RAPS.org
FDA
regulatory
COVID-19
vaccines
MRNA
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FDA to require new safety warnings for opioids
FDA to require new safety warnings for opioids
RAPS.org
FDA
regulatory
opioids
opioid crisis
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FDA outlines risk-based approach to monitoring clinical trials
FDA outlines risk-based approach to monitoring clinical trials
RAPS.org
clinical trials
regulatory
FDA
risk
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Study: Half of confirmatory studies for accelerated approvals are late
Study: Half of confirmatory studies for accelerated approvals are late
RAPS.org
JAMA
regulatory
accelerated approvals
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FDA floats oncology authorization shake-up, pitching 'one-trial' model for accelerated and full approval
FDA floats oncology authorization shake-up, pitching 'one-trial' model for accelerated and full approval
Fierce Biotech
FDA
oncology
regulatory
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FDA outlines plan for digital health technologies for clinical trials
FDA outlines plan for digital health technologies for clinical trials
RAPS.org
FDA
regulatory
clinical trials
digital health
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FDA will phase out 22 Covid-19 guidance documents as emergency declaration expires
FDA will phase out 22 Covid-19 guidance documents as emergency declaration expires
Endpoints
COVID-19
regulatory
FDA
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Researchers call on FDA to get tough on accelerated approval labeling
Researchers call on FDA to get tough on accelerated approval labeling
RAPS.org
FDA
regulatory
accelerated approval
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Woodcock: Pending ORA reorg will “modify things significantly” for all FDA regulated products
Woodcock: Pending ORA reorg will “modify things significantly” for all FDA regulated products
RAPS.org
FDA
ORA
regulatory
Janet Woodcock
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FDA has new leverage over companies looking for a quicker drug approval
FDA has new leverage over companies looking for a quicker drug approval
NPR
FDA
regulatory
accelerated approvals
drug approvals
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FDA seeks feedback on artificial intelligence in drug manufacturing
FDA seeks feedback on artificial intelligence in drug manufacturing
RAPS.org
regulatory
FDA
artificial intelligence
drug manufacturing
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FDA plans to launch communications pilot for promising rare disease gene therapies
FDA plans to launch communications pilot for promising rare disease gene therapies
RAPS.org
FDA
biologics
gene therapy
Rare Diseases
regulatory
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PhRMA official discusses legislative priorities, lessons from the pandemic
PhRMA official discusses legislative priorities, lessons from the pandemic
RAPS.org
PhRMA
legislation
pandemic
COVID-19
regulatory
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UK could allow reciprocal drug approvals with US FDA as soon as 2024
UK could allow reciprocal drug approvals with US FDA as soon as 2024
Endpoints
regulatory
drug approvals
FDA
UK
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Study: Extrapolation used in more than half of pediatric drug labeling changes
Study: Extrapolation used in more than half of pediatric drug labeling changes
RAPS.org
regulatory
pediatric
extrapolation
labeling
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This Week at FDA: Restructuring at inspections office, new guidances and staff, and more
This Week at FDA: Restructuring at inspections office, new guidances and staff, and more
RAPS.org
FDA
regulatory
regulatory inspections
Paxlovid
Jesduvroq
GSK
Pfizer
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FDA to resume in-person formal meetings in February
FDA to resume in-person formal meetings in February
RAPS.org
FDA
regulatory
pandemic
COVID-19
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This Week at FDA: Pallone pushes for greater ClinicalTrials.gov enforcement, FDA rejects Eli Lilly Alzheimer’s drug, and more
This Week at FDA: Pallone pushes for greater ClinicalTrials.gov enforcement, FDA rejects Eli Lilly Alzheimer’s drug, and more
RAPS.org
FDA
regulatory
clinical trials
clinicaltrials.gov
Eli Lilly
donanemab
Medtronic
BeiGene
Seagen
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FDA details approach for finding optimal dosages for new cancer drugs
FDA details approach for finding optimal dosages for new cancer drugs
RAPS.org
FDA
oncology
cancer
regulatory
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