FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more
Over the past year and as a result of the COVID-19 pandemic, FDA relied on alternative inspectional tools and approaches, including remote interactive evaluations and record requests, as well as a prioritization scheme, to...more
The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....more
Life science companies should consider offering FDA creative solutions for submissions that require pre-approval inspections....more
For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt...more
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact...more