Drug Manufacturers Beg US FDA To Inspect Facilities, But Still Find Difficulties
As agency implements testing program for its staff, sponsors are drawing up protocols to ensure inspector safety and forwarding them to FDA, but still can’t trigger an inspection.
You may also be interested in...
US FDA will determine on a case-by-case basis whether its inability to inspect a facility because of the pandemic could result in 180-day exclusivity forfeiture for first generic filers.
ANDA user fee goals likely would have to be reconfigured to account for business days and still maintain the intended length of time.
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.