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.
Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.
Proposed guidance revision adds nuance to manufacturing facility separation expectations for beta-lactam compounds that pose less risk of anaphylaxis than penicillin and related antibiotics.