The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns and exclusivity—these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. Recent news stories and high-profile trials concerning FDA-regulated products have made it clear that it is critical for attorneys who do not have regulatory practices and life sciences executives who deal with FDA-regulated products to have a familiarity with these concepts.

For this reason, ACI’s FDA Boot Camp returns for its 37th iteration, with the continued intent of providing these individuals with an essential working knowledge of core FDA concepts, and real world examples that will help them to excel in their everyday practices.

WilmerHale Partner Emily Whelan will speak during "Workshop C — Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group."