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Food, Drug & Device Compliance and Planning

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Alston & Bird offers an integrated international food, drug and medical device practice to help navigate the maze of regulatory compliance. Our practice provides legal services to makers of food and dietary supplements; drugs, including Rx, OTC, generic and animal; biologics, including monoclonal antibodies, viral vectors, RNA and DNA synthesis and gene transfer therapy; cosmetics; and medical devices and diagnostics and their clinical counterparts. Our team of regulatory lawyers performs all services required by an entity regulated by the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Health and Human Services Office of the Inspector General (HHS), the Centers for Medicare and Medicaid Services (CMS) and similar state agencies. To deal effectively with cross-border concerns, we maintain an active alliance with numerous non-U.S. law firms for dealing with international regulatory issues.