Archive for April 2020
Warning Letter Roundup: FDA Warns Six Foreign Drugmakers
The FDA sent warning letters to drug manufacturers in India, Korea, China and Denmark for serious violations at their facilities. Source: Drug GMP Report
Read MoreFDA Offers Advice on Adverse Event Reporting During a Pandemic
The FDA said it does not plan to object to delays in adverse event reporting for medical products during the pandemic. Source: Drug GMP Report
Read MoreFDA Strengthens Supply Chain Reporting During Pandemic
Manufacturers need to provide two-week updates on any supply issues during the COVID-19 emergency and going forward, the FDA said in a new straight-to-final guidance. Source: Drug GMP Report
Read MoreFDA Suspends Routine Inspections
The FDA has suspended routine domestic and foreign facility inspections in response to the COVID-19 outbreak. Source: Drug GMP Report
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