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Food & Drug Administration (“FDA”) Regulation | Williams & Connolly LLP

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These include advising on regulatory matters—e.g., citizen petitions, meetings with agency personnel, advisory committee meetings, general regulatory strategy—and compliance and enforcement—inspections, warning letters, disqualification and other administrative sanctions, injunction proceedings and criminal proceedings.

Firm lawyers have brought lawsuits against FDA, have represented clients intervening in lawsuits on the same side as FDA, and have represented executives of FDA-regulated companies at congressional hearings. They also successfully argued on behalf of the tobacco industry in the landmark Supreme Court decision invalidating the FDA's attempt to regulate tobacco.

Attorneys in our patent litigation practice routinely advise our brand clients on matters relating to Orange Book listings and ANDA filings with the FDA for our clients' NDA-approved drugs.

Email PagePrint to PDFShare PagePrimary ContactsStanley E. FisherPartnersfisher@wc.comD202-434-5289RELATED PROFESSIONALSNewsWilliams & Connolly Attorneys and Practice Areas Earn Rankings in the 2022 Edition of Chambers USAWilliams & Connolly Attorneys and Practice Areas Earn Rankings in the 2021 Edition of Chambers USAPublicationsFDA Regulation of Dietary Supplements: How We Got Here and What Lies AheadBenjamin Greenblum co-authors chapter in the Food & Drug Law Institute’s A Practical Guide to FDA’s Food & Drug Law and Regulation ContactCookie PolicyDisclaimerPrivacy PolicySitemap© 2026 Williams & Connolly LLP680 Maine Avenue SW, Washington DC 20024202.434.5000Email Williams & Connolly LLP Office

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