Regulatory Blog

As drug development continues to evolve, regulatory expectations are becoming increasingly focused on scientific rigor, product quality, and reliable clinical evidence. Two recently published U.S. Food and Drug Administration (FDA) guidances address important areas of pharmaceutical development—clinical investigations for psychedelic drugs and bioequivalence evaluation of topical dermatologic corticosteroids. While these guidances focus on different therapeutic areas, both em

Yesterday (October 21, 2022) USFDA Released multiple New draft guidelines providing guidance on topical generic drug product...