Beverly I. Chernaik | Read Bio
Office Director, Office of Regulations, FDA – CTP
BEVERLY CHERNAIK has been the Director of the Office of Regulations at the Center for Tobacco Products (CTP) of the Food and Drug Administration since 2010. The Office of Regulations at CTP is responsible for developing and drafting regulations, guidance documents, responses to citizen petitions, and other regulatory documents related to the review and regulation of tobacco products. Before joining CTP, Ms. Chernaik was an attorney in FDA’s Office of the Chief Counsel for more than 30 years. During that time, she provided the agency with legal advice and counsel on many areas, including medical device law, combination products, the Administrative Procedure Act, preemption, and federalism. She also handled both enforcement and defensive litigation, assisted the Solicitor General on several cases before the United States Supreme Court, and represented the agency in every type of administrative hearing at FDA. Ms. Chernaik clerked for Judge Cowen of the US Court of Appeals for the Federal Circuit, and received her B.A., magna cum laude, from the University of Massachusetts, and her J.D., cum laude, from Suffolk University Law School, where she was Note Editor of the Suffolk University Law Review.
Andrew E. Clark | Read Bio
Former Assistant Director, Consumer Protection Branch, Civil Division, DOJ
ANDREW CLARK concluded his service as Assistant Director of the Justice Department’s Consumer Protection Branch on July 31, 2020. Prior to his retirement, Mr. Clark oversaw the Branch’s defensive litigation practice, supervising the defense of actions brought against the Food and Drug Administration, the Consumer Product Safety Commission, the Federal Trade Commission, and other consumer protection agencies. Over the course of his nearly 36-year career at the Branch, first as a Trial Attorney, then as Senior Litigation Counsel, and finally as Assistant Director, Mr. Clark represented the FDA in a wide variety of affirmative and defensive matters, including dozens of cases arising under the Hatch Waxman Amendments involving challenges to generic drug approvals, contested exclusivity decisions, and other disputes that raised novel and complex issues of science and law.
Mr. Clark has lectured frequently on defending Administrative Procedure Act litigation and served for four years on the FDLI’s H. Thomas Austern Writing Awards Committee. He was previously recognized for his work on behalf of FDA with a Commissioner’s Special Citation and has twice received the DOJ Civil Division’s Dedicated Service Award for his record of actions and accomplishments at the Department of Justice. Most recently, he was presented with the Assistant Attorney General’s Career Service Award in recognition of his commitment to the mission of the Civil Division for over 30 years. Mr. Clark joined the Justice Department through the Attorney General’s Honors Program in 1984 following a clerkship with Judge Stephanie K. Seymour on the U.S. Court of Appeals for the Tenth Circuit. He is a 1980 cum laude graduate of Williams College and received his J.D. cum laude from Georgetown University Law Center in 1983.
Jonathan S. Kahan | Read Bio
Partner, Hogan Lovells US LLP
JONATHAN KAHAN is a partner in the Washington, DC office of Hogan Lovells US LLP. With more than 40 years of legal experience, Jonathan is an industry leader in obtaining FDA market clearance of novel medical devices for medical technology and diagnostics companies. He also advises on post-market compliance matters and helps clients navigate complicated regulatory processes including those related to combination products such as combinations of devices, drugs, biologics, and human tissues. He authored the leading text on medical device law, Medical Device Development: Regulation and Law (Parexel 2020). Jonathan is the former co-director of the firm’s Medical Device and Technology Practice Group and an adjunct professor who teaches medical device law at the George Washington University Law School. He presently serves as a member of the George Washington University President’s Leadership Advisory Council and is also the general counsel of the Association of Medical Diagnostics Manufacturers. Jonathan is highly ranked by Chambers as well as all other rating services, and has been consistently included in Washington, DC Super Lawyers and Washingtonian Magazine’s Top Lawyers in DC.