inspections

Nearly 2,000 drug manufacturing plants are overdue for FDA inspections after Covid delays
Stat
Thu, 09/5/24 - 11:34 am
regulatory
drug manufacturing
inspections
FDA
What FDA might consider as delaying or denying an inspection: New guidance spells out the specifics
Endpoints
Mon, 12/19/22 - 10:15 pm
regulatory
FDA
inspections
Bags of shredded docs: Indian drugmaker Lupin handed a Form 483 by FDA inspectors
Endpoints
Sun, 12/11/22 - 01:29 pm
Lupin
generics
regulatory
FDA
inspections
FDA pauses domestic drug inspections again, this time to protect against Omicron
Endpoints
Wed, 01/5/22 - 10:36 am
FDA
inspections
regulatory
COVID-19
Omicron COVID-19 variant
New drug applications pile up with delays as there's no easy fix for the inspection backlog
Endpoints
Tue, 11/23/21 - 09:52 am
FDA
regulatory
inspections
pandemic
COVID-19
CPhI: As Covid-19 restrictions ease, an inspection backlog could have a big effect on new drugs, generics
Endpoints
Thu, 11/11/21 - 11:09 am
CPhI
pandemic
FDA
regulatory
COVID-19
inspections
generics
Pandemic creates 500-site backlog for FDA, despite decade of dwindling US inspections
Pharma Tech
Thu, 05/27/21 - 12:00 am
FDA
inspections
regulatory
COVID-19
pandemic
FDA’s inspection backlog: GAO raises concerns as delays mount
RAPS.org
Tue, 03/9/21 - 09:45 pm
FDA
GAO
inspections
regulatory
Drugmakers push the FDA to resume inspections after drug approvals delayed, denied
Beckers Hospital Review
Tue, 03/2/21 - 11:58 pm
FDA
drug approvals
inspections
FDA won't require manufacturing inspections for emergency COVID-19 vaccine use: Bloomberg
Fierce Pharma
Mon, 10/26/20 - 11:08 pm
FDA
COVID-19
vaccines
drug manufacturing
inspections
FDA readies overhaul of inspection program
Mass Device
Wed, 03/29/17 - 11:53 am
FDA
inspections
device manufacturing
devices
drug manufacturing
Indian Regulators to Shadow U.S. FDA on Plant Inspections
Bloomberg
Wed, 02/12/14 - 09:09 am
India
inspections
FDA
drug manufacturing
The Top 10 Reasons Why Drug, Device, Biologic, Research and Veterinary Facilities Fail FDA Inspections
Regulatory Focus
Tue, 02/11/14 - 08:54 am
devices
animal health
inspections
drug manufacturing
Broker offers protection to pharma groups
FT.com
Mon, 07/25/11 - 10:24 am
regulatory inspections
inspections
business insurance
Medical device makers won't pay for state inspections (in FL)
Fri, 07/9/10 - 01:35 pm
inspections