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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.

Full Bio

Credentials

U.S. Court of Appeals for the Fourth Circuit

U.S. Court of Appeals for the Fifth Circuit

U.S. District Court for the District of Columbia

District of Columbia

Montana

Matters

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.

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Matters

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.

Helped clients respond to 483 inspectional observations issued by FDA investigators and Warning and Untitled Letters issued by FDA officials.

Assisted clients who have had facilities or products placed on an import alert or the application integrity policy.

Advised clients on issues related to the practices of medicine and pharmacy, including issues related to compounding and the distinction between traditional pharmacy compounding and outsourcing facilities.

Represented companies in interactions with regulatory officials from the FDA, HHS and DEA.

Assisted clients with due diligence on FDA-regulated entities.

Advised clients on issues related to drug shortages.

Assisted companies with FDA's review of proprietary drug names.

Assisted companies in government investigations involving data integrity, healthcare fraud and abuse, qui tam lawsuits, preemption, off-label promotion, misbranding, adulteration and the Anti-Kickback Statute, along with criminal, civil and administrative enforcement actions and related civil litigation regarding the same.

Helped companies negotiate consent decrees with FDA and DOJ and corporate integrity agreements with HHS's Office of the Inspector General.

Advised clients regarding "intended use" and the types of claims that distinguish drugs and devices from cosmetics, dietary supplements and food.

Reviewed labeling of drugs, both Rx and OTC, biologics, devices, dietary supplements, food and cosmetics for compliance with the FD&C Act.

Advised clients on Rx to OTC switches.

Counseled clients on legal issues related to the design and implementation of clinical trials, including the preparation of investigational new drug (IND) applications and investigational device exemption (IDE) applications and the submission of information to the clinical trial registry and the new clinical trial results database.

Provided clients with crisis management counseling on product recalls, government inspections and seizures, adverse events and similar issues.

Served as an expert witness on FDA regulatory issues in multiple cases.

Matters

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
Icon close

Close

Matters

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.

Helped clients respond to 483 inspectional observations issued by FDA investigators and Warning and Untitled Letters issued by FDA officials.

Assisted clients who have had facilities or products placed on an import alert or the application integrity policy.

Advised clients on issues related to the practices of medicine and pharmacy, including issues related to compounding and the distinction between traditional pharmacy compounding and outsourcing facilities.

Represented companies in interactions with regulatory officials from the FDA, HHS and DEA.

Assisted clients with due diligence on FDA-regulated entities.

Advised clients on issues related to drug shortages.

Assisted companies with FDA's review of proprietary drug names.

Assisted companies in government investigations involving data integrity, healthcare fraud and abuse, qui tam lawsuits, preemption, off-label promotion, misbranding, adulteration and the Anti-Kickback Statute, along with criminal, civil and administrative enforcement actions and related civil litigation regarding the same.

Helped companies negotiate consent decrees with FDA and DOJ and corporate integrity agreements with HHS's Office of the Inspector General.

Advised clients regarding "intended use" and the types of claims that distinguish drugs and devices from cosmetics, dietary supplements and food.

Reviewed labeling of drugs, both Rx and OTC, biologics, devices, dietary supplements, food and cosmetics for compliance with the FD&C Act.

Advised clients on Rx to OTC switches.

Counseled clients on legal issues related to the design and implementation of clinical trials, including the preparation of investigational new drug (IND) applications and investigational device exemption (IDE) applications and the submission of information to the clinical trial registry and the new clinical trial results database.

Provided clients with crisis management counseling on product recalls, government inspections and seizures, adverse events and similar issues.

Served as an expert witness on FDA regulatory issues in multiple cases.

Credentials

U.S. Court of Appeals for the Fourth Circuit

U.S. Court of Appeals for the Fifth Circuit

U.S. District Court for the District of Columbia

District of Columbia

Montana