Rebecca L. Dandeker

Partner

Rebecca L. Dandeker is a partner in Morgan Lewis's FDA Practice. Ms. Dandeker provides counseling in the area of prescription and nonprescription pharmaceuticals, as well as other consumer products, such as dietary supplements, cosmetics, and alternative therapies. She has handled regulatory and policy matters pertaining to drugs, including innovators and generics, clinical studies, Drug Efficacy Study Implementation (DESI), over-the-counter (OTC) drug products, Rx-to-OTC switches, and homeopathy, with a particular emphasis on pharmaceutics.

Ms. Dandeker routinely advises companies with FDA-regulated products-including manufacturers, distributors, pharmacies, healthcare providers, clinical investigators, and entrepreneurs-on regulatory strategy, compliance issues, enforcement actions, and labeling and advertising matters. She also assists clients by challenging FDA policies and administrative decisions through informal correspondence, rulemaking proceedings, citizen petitions, and litigation. Ms. Dandeker's experience includes the federal, state, and international regulation of drugs, as well as interaction with the U.S. Food and Drug Administration, the Federal Trade Commission, the U.S. Drug Enforcement Administration, and the U.S. Customs Service. She also has drafted policy papers and congressional testimony for clients involved with legislative matters.

Ms. Dandeker has written and spoken on various FDA-related topics, including the FDA's generic drug approval process, FDA inspections, and compliance audits. Additionally, she has co-authored several articles in the Journal of cGMP Compliance.

Prior to joining Morgan Lewis, Ms. Dandeker was a partner in the food and drug practice of another international law firm, resident in Washington, D.C. She also previously served as a law clerk for Judge Robert W. Stewart in the Fourth Judicial Circuit of Virginia.

Ms. Dandeker earned her J.D. from Georgetown University Law Center in 1994, where she was the topics editor for Law & Policy in International Business and authored a note titled "The Rose Garden Agreement: Is Mercosur the Next Step to a Hemispheric Free Trade Zone?" She earned her B.S., magna cum laude, in political science from Liberty University in 1989.