Early GMP Compliance Seen As A Key To Avoiding Complete Responses
Former FDA compliance official offers advice to biotech startups on how to avoid CMC and GMP complete responses.
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'Concept of Operations' document spells out how FDA's realigned inspectorate and program offices will work together to accelerate drug manufacturing facility evaluations and inspections in line with generic and brand drug product reviews. Under the new approach, the agency expects to produce establishment inspection reports, facility classifications and warning letters more quickly, giving applicants more time to avoid manufacturing-related complete response letters.
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.
The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.