regulatory

FDA names chief scientist Bumpus as Woodcock’s successor
FDA names chief scientist Bumpus as Woodcock’s successor
BioPharma Dive
FDA
regulatory
Janet Woodcock
Namandjé Bumpus
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FDA's oncology office uses advisory committee to spotlight timely accelerated approval confirmation
FDA's oncology office uses advisory committee to spotlight timely accelerated approval confirmation
Fierce Pharma
FDA
regulatory
oncology
cancer
accelerated approvals
Acrotech Biopharma
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FDA could furlough nearly one-fifth of staff by Sunday
FDA could furlough nearly one-fifth of staff by Sunday
RAPS.org
FDA
government shutdown
regulatory
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FDA's single-trial guidance calls for the good, bad and ugly data to support effectiveness
FDA's single-trial guidance calls for the good, bad and ugly data to support effectiveness
Fierce Biotech
FDA
clinical trials
regulatory
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FDA Finalizes Human Factors Guidance in Combination Medical Devices
FDA Finalizes Human Factors Guidance in Combination Medical Devices
Medical Devices and Diagnostics Industry
Medtech
devices
FDA
regulatory
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This Week at FDA: A glut of guidances
This Week at FDA: A glut of guidances
RAPS.org
FDA
regulatory
CDRH
CDER
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FY22 Drug Recalls Highest in Five Years: FDA Report
FY22 Drug Recalls Highest in Five Years: FDA Report
BioSpace
FDA
drug manufacturing
product recalls
regulatory
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FDA’s workforce goals: tackling recruitment, retention and burnout
FDA’s workforce goals: tackling recruitment, retention and burnout
Medical Marketing and Media
FDA
regulatory
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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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