Christopher Pruitt Email & Phone Number

Brings deep government and private-practice experience advising on Food & Drug Administration legal and regulatory issues, particularly involving the Hatch-Waxman Amendments and the regulation of human drugs. Possesses significant experience managing staff and subordinate supervisors, operationalizing complex legal and regulatory mandates, and providing policy advocacy before senior Agency and Department leadership and external stakeholders.Currently, Deputy Director of the Office of Generic Drug Policy, overseeing three divisions and an interdisciplinary staff of approximately 50 people. Oversees and supports OGDP's programs and activities including:- Providing strategic advice on a wide-range of Hatch-Waxman regulatory issues, including approval standards, labeling carve-outs, sameness requirements, patent certification, and thirty-month stays.- Tracking and determining 180-day exclusivity eligibility and forfeitures.- Publication of the Orange Book, including determining eligibility for new drug exclusivities and assessing therapeutic equivalence ratings.- Strategic development, clearance, and publication of guidance documents, MAPPs, and regulations in support of GDUFA commitments, the Drug Competition Action Plan, and other Agency, Center, and OGD initiatives. - Development of citizen petition responses affecting generic drugs. - Managing OGD's suitability petition program, including development and clearance of responses.

Listed skills include Legal Research, Litigation, Legal Writing, and Civil Litigation.