1111 Pennsylvania Ave. NW\\Washington, DC 20004-2541\\United States
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.
Rebecca’s experience includes US federal, state, and international drug regulation, as well as interaction with the FDA, the Federal Trade Commission (FTC), the US Drug Enforcement Administration (DEA), and the US Customs Service. She routinely advises clients on regulatory strategy, compliance issues, enforcement actions, and matters involving labeling and advertising.
She helps clients challenge FDA policies and administrative decisions through informal correspondence, rulemaking proceedings, citizen petitions, and litigation. Rebecca also drafts policy papers and congressional testimony for clients involved in legislative disputes.
Rebecca publishes and speaks on a range of FDA-related topics, including the agency’s generic drug approval process, 505(b)(2) NDA requirements, inspections/compliance audits, and labeling and advertising rules.
Prior to joining Morgan Lewis, Rebecca was a partner in the food and drug practice of another international law firm, resident in Washington, DC.
Awards and Affiliations
Member, Federal Bar Association
Member, Food and Drug Law Institute
Member, Maryland Bar Association
Member, National Association of Boards of Pharmacy