Generic Drug Covid-19 Successes Touted

CDER director Patrizia Cavazzoni says the work of the generic drug program during the Covid-19 pandemic is a prime example of how well CDER operated in difficult circumstances. In a memo to staff, Cavazzoni says, “Through cross-office collaboration, the program has been using new approaches during the pandemic to move applications forward quickly and efficiently.” She cites these Covid-19-related accomplishments: 

•         the review and approval of 1,500+ Covid-related ANDAs consisting of over 80 original ANDAs and over 1,400 supplements;
•         the development of novel approaches and alternatives to inspections of manufacturing facilities and bioavailability analytical and clinical sites for FDA-regulated products;
•         the use of new tools with a real-time capability to ensure ANDA approvals could happen without delays; and
•         prioritizing Covid-related applications.