US FDA Mulls Possibility Of Preannouncing Post-COVID Domestic Surveillance Inspections
Criticized for giving foreign sites advance notice of inspections, agency is considering giving such notice to domestic sites too even after surprise inspections become possible.
You may also be interested in...
Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.
Dr Reddy’s global head of quality outlines how the company leveraged digitization to keep plants running at full throttle amid the pandemic and went on to operationalize a site for remdesivir designed as a "lights out" facility. Certain facilities at the Indian firm have also undergone remote inspections by major regulatory agencies.
Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.