Day: August 11, 2022

Safety report for serious adverse events (SAE) observed in bioequivalence/bioavailability (BA/BE) studies are submitted as FDA MedWatch Forms (FDA 3500A Form) to the FDA. Going forward, FDA requires that sponsors of BA/BE studies submit SAE reports electronically via the ESG or the Safety Reporting Portal (SRP) only. The purpose of such reporting is to make … Read more

An independent review found many errors about the start and completion timelines for clinical trials reported on the clinicaltrials.gov registry. It also found that NIH and FDA have no mechanism to police the inaccuracies in the reported study timelines. The errors primarily emanate from the lack of standardization of the definition of the start and … Read more