advocacy + government relations

FDA Regulatory Counsel's Washington, DC practice provides subject matter expertise to government relations teams supporting stakeholders in FDA-regulated industries. As regulatory lawyers we are uniquely able to educate legislators and regulators on developing laws, regulations, public policiy and enforcement guidelines under FDA's umbrella.

FDARC is particularly focused on innovative life sciences and emerging industries. We have counseled lawmakers on the precedent and implications of changing regulation, including:


  • Dietary Supplement Health and Education Act (DSHEA)

  • Medical device 510(k) process overhaul

  • MHealth guidelines

  • Advertising, off-label claims and scientific exchange policies

  • 503B Compounding Pharmacy Act

  • Tobacco Deeming Rule (e-cigarettes/vape)

  • CBD and cannabis policy

Representative Matters

  • Liaise with government and regulatory bodies, including FDA, on regulated products, scientific information, formal and informal inquiries, and legislative and regulatory policies.

  • Draft comments and responses to regulatory dockets, proposed laws and regulations, FDA guidance documents, and industry group policy positions.

  • Inform and shape advocacy before Congress, FDA, and other federal and state bodies and agencies with respect to existing and emerging regulatory policies.

Please contact us for more information on our regulatory affairs, public policy, advocacy, and government relations offerings.

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© 2020  by FDA Regulatory Counsel LLP


This site is not intended to be legal advice. Contacting the firm or reading the materials on the site does not create an attorney-client relationship. No confidential information should be sent over the internet. Past results do not predict future outcomes as each situation has to stand on its own. Melissa Gilmore is licensed to practice law in the District of Columbia, New York (inactive), and California (inactive). Donato J. Borrillo is licensed to practice law in Ohio.