DRUG DISCOVERY DEVELOPMENT (DDD): CHANGES TO AN APPROVED PRODUCT

ANY CHANGE made to an FDA- approved drug
product- components, chemical synthesis, analytical
methods, manufacturing site, process, batch size,
labeling- must be reported

1 __ - requires FDA approval prior to implementation of
change

Question

CHANGES TO AN APPROVED PRODUCT

ANY CHANGE made to an FDA- approved drug
product- components, chemical synthesis, analytical
methods, manufacturing site, process, batch size,
labeling- must be reported

1 __ - requires FDA approval prior to implementation of
change

LEIGHTON DWIGHT OBILLOS · Accepted Answer

1 Scale-up and Post-approval Changes (SUPAC)

DRUG DISCOVERY DEVELOPMENT (DDD)

CHANGES TO AN APPROVED PRODUCT ANY CHANGE made to an FDA- approved drug product- components, chemical synthesis, analytical methods, manufacturing site, process, batch size, labeling- must be reported 1 __ - requires FDA approval prior to implementation of change

1 Scale-up and Post-approval Changes (SUPAC)

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