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2022.10
Big News: FDA issued the finalized version of guidance “Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA”
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (October 2022)On October 13, 2022, the FDA (CDER and CBER) issued the...