To help industry better understand the agency’s latest thinking on when it may require clinical trials or postmarket studies for already-approved https://nizagara-online.net prescription drugs, the U.S. Food and Drug Administration (FDA) has released a draft revision of guidance on “Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.”
The revision offers new details on when the FDA’s Adverse Event Reporting System and Vaccine Adverse Event Reporting System may be sufficient for identifying and assessing new serious adverse drug events that occur rarely, are closely linked in time to the initiation of the drug, and for which the background rate of events is low.
Broadly speaking, postmarketing studies and clinical trials may be required for any or all of these three reasons:
- To assess a known risk related to the use of the drug.
- To assess signals of serious risk related to the use of the drug.
- To identify an unexpected serious risk when available data indicate the potential for a serious risk.
The new guidance is chock full of detail applicable to a number of scenarios. It also lays out definitions for clinical trials designed with safety endpoints in mind, and clinical trials intended to further assess or identify a serious risk related to failure of expected pharmacological action.
Author: Michael Causey