04 Aug What types of postmarketing studies are required after approval by the FDA
consider post-market studies (a.k.a phase IV trials). You are working at a non-profit that is considering lobbying FDA and congress to change the laws/guidances regarding Phase IV trials. As the only scientist in the office as well as the head of regulatory, you need to brief your boss (the head of the congressional affairs office) on the science behind the policy (remember your boss is an MBA and not a scientist) and how the non-profit’s proposed policy change (mandating FDA always set a time limit on the length of Phase IV trials) does or does not make sense from a scientific point of view. Write a one to two pages essay describing how you would prepare for the meeting with your boss and how you would discuss the above topics during the meeting.
( 2) What types of postmarketing studies are required after approval by the FDA?
(3) What occurs after the submission of a BLA? Is it different from an ANDA or NDA? How much time does the FDA have to respond to a submission?
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