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Sheldon Bradshaw counsels clients whose products are regulated by the Food and Drug Administration (FDA). A partner in our FDA and Life Sciences practice with a focus on life sciences and healthcare, Sheldon provides legal and regulatory advice to companies ranging from small growth firms to large multinational corporations.
Previously, Sheldon served as Chief Counsel of the FDA from 2005 to 2007. In that role, he provided legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services, as well as to FDA's senior leadership, on issues relating to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other regulated products.
As FDA Chief Counsel, Sheldon also supervised all agency litigation, and reviewed and cleared every significant FDA regulation, guidance document and warning letter issued by the Agency.
Before joining the FDA, Sheldon held senior positions at the U.S. Department of Justice (DOJ), where, among other responsibilities, he provided advice to the FDA and testified before Congress on matters under the FDA’s jurisdiction.
District of Columbia
Montana
U.S. Court of Appeals for the Fourth Circuit
U.S. Court of Appeals for the Tenth Circuit
U.S. District Court for the District of Columbia
U.S. District Court for the District of Montana
April 1, 2016
King & Spalding Boosts FDA & Life Sciences Practice with Addition of Three-Lawyer Team in Washington, D.C.
Advised pharmaceutical companies on drug approval strategies involving new drug applications, 505(b)(2) applications, suitability petitions, and abbreviated new drug applications (ANDAs); biotech companies on biologics licensing strategies involving biologics licensing applications (BLAs) and biosimilars; and device manufacturers on 510(k) and pre-market approval (PMA) applications and FDA's de novo classification process.
Counseled clients regarding product life cycle management (including the development of new products and line extensions), Hatch-Waxman issues (including patent and non-patent exclusivities, 30-month stays and FDA's Orange Book), user fees, and risk evaluation and mitigation strategies (REMS).
Assisted pharmaceutical, biotech and device manufacturers with post-approval issues, including labeling changes, manufacturing changes, adverse event reporting, current good manufacturing practice requirements (cGMPs) and promotional activities.
See more
April 1, 2016
King & Spalding Boosts FDA & Life Sciences Practice with Addition of Three-Lawyer Team in Washington, D.C.
Advised pharmaceutical companies on drug approval strategies involving new drug applications, 505(b)(2) applications, suitability petitions, and abbreviated new drug applications (ANDAs); biotech companies on biologics licensing strategies involving biologics licensing applications (BLAs) and biosimilars; and device manufacturers on 510(k) and pre-market approval (PMA) applications and FDA's de novo classification process.
Counseled clients regarding product life cycle management (including the development of new products and line extensions), Hatch-Waxman issues (including patent and non-patent exclusivities, 30-month stays and FDA's Orange Book), user fees, and risk evaluation and mitigation strategies (REMS).
Assisted pharmaceutical, biotech and device manufacturers with post-approval issues, including labeling changes, manufacturing changes, adverse event reporting, current good manufacturing practice requirements (cGMPs) and promotional activities.
See more
April 1, 2016
King & Spalding Boosts FDA & Life Sciences Practice with Addition of Three-Lawyer Team in Washington, D.C.
District of Columbia
Montana
U.S. Court of Appeals for the Fourth Circuit
U.S. Court of Appeals for the Tenth Circuit
U.S. District Court for the District of Columbia
U.S. District Court for the District of Montana