Epstein Becker Green drafted and submitted a citizen petition to the Food and Drug Administration (FDA) on behalf of a client, raising safety concerns about a first-in-class drug and asking the FDA to take a closer look at those issues before approval. The FDA referred the application for review by an advisory committee (ADCOM), while EBG submitted comments for the ADCOM’s consideration. Consistent with the ADCOM’s recommendation, the FDA requested that the applicant conduct an additional clinical trial before it again considers approval of the drug.
