Rebecca Dandeker represents clients in matters involving products regulated by the US Food and Drug Administration (FDA), including prescription and nonprescription pharmaceuticals, dietary supplements, cosmetics, and alternative therapies. Rebecca advises on diverse regulatory, policy, and compliance issues pertaining to pharmaceuticals, including preapproval pathways for innovators and generics, clinical studies, Hatch-Waxman issues, Drug Efficacy Study Implementation (DESI) drugs, over-the-counter (OTC) monograph drugs, homeopathics, Rx-to-OTC switches, and postapproval compliance. Her clients range from manufacturers, distributors, and pharmacies to healthcare providers, clinical investigators, and entrepreneurs.
