regulatory inspections

Califf addresses inspections, staffing and COVID response in House hearing
Califf addresses inspections, staffing and COVID response in House hearing
RAPS.org
FDA
Robert Califf
COVID
regulatory inspections
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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 official discusses benefits, challenges of remote inspections
FDA official discusses benefits, challenges of remote inspections
RAPS.org
regulatory
FDA
remote inspections
regulatory inspections
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Biosimilar inspections still lagging as the FDA looks to clear its backlog
Biosimilar inspections still lagging as the FDA looks to clear its backlog
Endpoints
biosimilars
FDA
regulatory
regulatory inspections
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FDA’s OPQ 2021 report focuses on pandemic responses
FDA’s OPQ 2021 report focuses on pandemic responses
RAPS.org
FDA
regulatory
pandemic
OPQ
regulatory inspections
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FDA's domestic inspection hold will continue until February
FDA's domestic inspection hold will continue until February
Endpoints
FDA
regulatory
regulatory inspections
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House committee seeks more from FDA on inspection backlog, when to restart work on foreign sites
House committee seeks more from FDA on inspection backlog, when to restart work on foreign sites
Endpoints
FDA
regulatory
foreign inspections
regulatory inspections
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FDA’s domestic biopharma inspections return to normal as agency faces backlog of 8,000+
FDA’s domestic biopharma inspections return to normal as agency faces backlog of 8,000+
Endpoints
FDA
regulatory
regulatory inspections
Janet Woodcock
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FDA Lays Out Roadmap to Clear Inspection Backlog as Biomanufacturing Booms
FDA Lays Out Roadmap to Clear Inspection Backlog as Biomanufacturing Booms
BioSpace
drug manufacturing
FDA
regulatory inspections
pandemic
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FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion
FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion
Endpoints
FDA
Emergent BioSolutions
regulatory inspections
drug manufacturing
vaccines
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FDA inspection of Emergent’s Baltimore site in 2020 raises new questions
FDA inspection of Emergent’s Baltimore site in 2020 raises new questions
Endpoints
JNJ
Emergent BioSolutions
drug manufacturing
FDA
regulatory inspections
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Special Counsel raises questions about FDA’s biologics inspections
Special Counsel raises questions about FDA’s biologics inspections
RAPS.org
FDA
biologics
regulatory inspections
regulatory
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FDA Fiddles With Remote Drug Inspections While Pharma Burns
FDA Fiddles With Remote Drug Inspections While Pharma Burns
FDA Law Blog
FDA
pandemic
regulatory inspections
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Drug rejections rise as Covid-19 bites
Drug rejections rise as Covid-19 bites
EP Vantage
COVID-19
drug approvals
Alkermes
ALKS 3831
pandemic
regulatory inspections
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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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FDA postpones some inspections of U.S. manufacturing facilities
FDA postpones some inspections of U.S. manufacturing facilities
Stat
FDA
regulatory inspections
drug manufacturing
COVID-19
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Senate bill aims to streamline FDA inspections process
Senate bill aims to streamline FDA inspections process
Mass Device
FDA
Senate
regulatory inspections
devices
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Broker offers protection to pharma groups
Broker offers protection to pharma groups
FT.com
regulatory inspections
inspections
business insurance
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