NCHR Comments to FDA on the Draft Guidance Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act

September 12, 2023: Noncompliance with required post-market studies (PMRs) is a serious problem that undermines FDA’s authority and the public trust in FDA decision-making.NCHR supports the process described in the guidance for applicants to correct circumstances that led to non-compliance with the agreed upon PMRs; however, we urge that the description of the actions taken by the applicant to address these issues be more explicit and less subjective. 

Read More »