The FDA released guidance on Tuesday (4/28) for bioequivalence studies intended for submission in Abbreviated New Drug Applications (ANDAs). Due to Covid, many clinical trial studies have been negatively impacted due to travel limitations, site closures, etc. With these new guidelines, the FDA emphasizes the importance of the study participant’s safety as they look at restarting their studies, as well as advises generic drugmakers on potential protocol changes and the collection of data from studies in these unprecedented times. 

Read more here

More on: