Home » FDA Should Be More Specific on Postmarketing Requirement Triggers
FDA Should Be More Specific on Postmarketing Requirement Triggers
Stakeholders are telling the FDA that
a July draft guidance on postmarketing studies should
have described the safety signals the agency uses to determine that a postmarket clinical trial or study will be required. PhRMA says in comments posted
on the FDA’s website that a final guidance also should outline the types of risks that would prompt the FDA to require postmarketing studies and
clinical trials.
Drug Industry Daily
Drug Industry Daily
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