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Joshua S. Kim
Associate
jkim@kkblaw.com

Joshua Kim's practice focuses on the U.S. Food and Drug Administration's regulation of pharmaceutical, biological and food products. Mr. Kim has also represented medical device, dietary supplement, and cosmetic companies. His experience includes the federal, state, and international regulation of products and activities under the jurisdiction of the FDA, the Consumer Product Safety Commission, the Drug Enforcement Administration, the Federal Trade Commission, and the U.S. Department of Agriculture.

Mr. Kim advises clients on issues arising under the Hatch-Waxman Amendments, such as the approval pathways presented by sections 505(b)(1), 505(b)(2), and 505(j) of the Federal Food, Drug, and Cosmetic Act. He has counseled clients on the regulation of over-the-counter drugs, DESI drugs, and combination products. Mr. Kim assists clients on policy and administrative matters that require the drafting of FDA-related documents ranging from citizen petitions to informal correspondence. His experience also includes matters concerning food safety, food processing, Generally Recognized As Safe (GRAS) ingredients, and the registration of facilities under the Bioterrorism Act of 2002.

Mr. Kim earned his J.D. from Harvard Law School and his B.A., summa cum laude, from Yale University, where he was one of only fourteen individuals in his class (top 1%) elected into Phi Beta Kappa in the junior year. Prior to joining KKB, Mr. Kim practiced food and drug law as an associate at prominent law firms in Washington, D.C.

Education:
Harvard Law School, J.D., 2003

Yale University, B.A., summa cum laude, 2000
Phi Beta Kappa Junior Year, Distinction in the Major

Professional Affiliations
District of Columbia Bar
Maryland Bar

Practice Credentials
District of Columbia Court of Appeals
Maryland Court of Appeals
U.S. District Court for the District of Maryland

Foreign Languages
Korean

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