William McConagha
USA Guide 2023
Band 2 : Healthcare: Pharmaceutical/Medical Products Regulatory
Email address
[email protected]Contact number
+1 202.371.7350Share profile
Band 2
About
Provided by William McConagha
Practice Areas
Nationally recognized lawyer in FDA law who has a unique combination of experience in enforcement, regulatory and legislative matters. Deep experience with FDA regulatory requirements and compliance issues, including those related to current Good Manufacturing Practice, Quality System Regulation, the Food Safety Modernization Act, post-market safety reports, product recalls, pharmacy compounding, HCT/Ps, dietary supplements, innovative food technologies, premarket approval of medical products, clinical trial regulation, expanded access programs, cosmetics, software as a medical device (SaMD), the Prescription Drug Marketing Act, the track-and-trace regulations for prescription drugs, and emergency use authorizations. Advises companies and provides counsel on drafting responses to warning letters, FDA 483s, import alerts, civil and criminal FDA enforcement actions, and prescription drug advertising and promotion. Also advises companies regarding internal investigations, congressional oversight and investigations related to FDA products, and technical legal questions involving the Food, Drug and Cosmetic Act, and the Administrative Procedure Act. Also works extensively on corporate transactions involving FDA-regulated companies, both in performing diligence (including claims review) and revising deal documents.
Career
FDA Assistant Commissioner; FDA Associate Chief Counsel; Health Policy Advisor to the Senate Committee on Health, Education, Labor and Pensions (HELP); J.D., Georgetown University, (cum laude); B.A., Carleton College, (magna cum laude)
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