consider post-market studies (a.k.a phase IV trials). You are working at a non-p

Question

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 nonprofit'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.

Explanation / Answer

Setting a mandatory minimum time period for Phase IV studies makes sense, as it give an idea about the long term effects of the drug. As the individual using the drug will carry on with their normal schedule, it will increase the chances of a drug-drug or drug-food interaction to be discovered. Phase IV studies are data driven, as the user base is much larger than all previous studies combined and gives a larger scope for finding out any problems with the drug.

Related Questions

Navigate

• Browse (All)
• Browse C
• Subjects

Integrity-first tutoring: explanations and feedback only — we do not complete graded work. Learn more.