regulatory inspections

Califf addresses inspections, staffing and COVID response in House hearing
RAPS.org
Wed, 02/8/23 - 11:02 pm
FDA
Robert Califf
COVID
regulatory inspections
This Week at FDA: Restructuring at inspections office, new guidances and staff, and more
RAPS.org
Mon, 02/6/23 - 10:34 am
FDA
regulatory
regulatory inspections
Paxlovid
Jesduvroq
GSK
Pfizer
FDA official discusses benefits, challenges of remote inspections
RAPS.org
Sun, 11/20/22 - 12:38 pm
regulatory
FDA
remote inspections
regulatory inspections
Biosimilar inspections still lagging as the FDA looks to clear its backlog
Endpoints
Fri, 07/22/22 - 10:11 am
biosimilars
FDA
regulatory
regulatory inspections
FDA’s OPQ 2021 report focuses on pandemic responses
RAPS.org
Wed, 02/23/22 - 10:02 pm
FDA
regulatory
pandemic
OPQ
regulatory inspections
FDA's domestic inspection hold will continue until February
Endpoints
Mon, 01/24/22 - 10:13 am
FDA
regulatory
regulatory inspections
House committee seeks more from FDA on inspection backlog, when to restart work on foreign sites
Endpoints
Mon, 07/26/21 - 10:15 pm
FDA
regulatory
foreign inspections
regulatory inspections
FDA’s domestic biopharma inspections return to normal as agency faces backlog of 8,000+
Endpoints
Mon, 07/19/21 - 11:07 am
FDA
regulatory
regulatory inspections
Janet Woodcock
FDA Lays Out Roadmap to Clear Inspection Backlog as Biomanufacturing Booms
BioSpace
Sat, 05/29/21 - 04:51 pm
drug manufacturing
FDA
regulatory inspections
pandemic
FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion
Endpoints
Wed, 04/21/21 - 10:36 am
FDA
Emergent BioSolutions
regulatory inspections
drug manufacturing
vaccines
FDA inspection of Emergent’s Baltimore site in 2020 raises new questions
Endpoints
Thu, 04/8/21 - 07:46 pm
JNJ
Emergent BioSolutions
drug manufacturing
FDA
regulatory inspections
Special Counsel raises questions about FDA’s biologics inspections
RAPS.org
Thu, 04/1/21 - 10:56 am
FDA
biologics
regulatory inspections
regulatory
FDA Fiddles With Remote Drug Inspections While Pharma Burns
FDA Law Blog
Thu, 12/10/20 - 10:43 am
FDA
pandemic
regulatory inspections
Drug rejections rise as Covid-19 bites
EP Vantage
Wed, 11/18/20 - 01:20 pm
COVID-19
drug approvals
Alkermes
ALKS 3831
pandemic
regulatory inspections
FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections
Fierce Pharma
Mon, 07/13/20 - 11:27 pm
FDA
regulatory
drug manufacturing
pandemic
COVID-19
regulatory inspections
FDA postpones some inspections of U.S. manufacturing facilities
Stat
Wed, 03/18/20 - 11:51 pm
FDA
regulatory inspections
drug manufacturing
COVID-19
Senate bill aims to streamline FDA inspections process
Mass Device
Fri, 02/17/17 - 10:11 am
FDA
Senate
regulatory inspections
devices
Broker offers protection to pharma groups
FT.com
Mon, 07/25/11 - 10:24 am
regulatory inspections
inspections
business insurance