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U.S. Department of Health and Human Services

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Beverly Chernaik, JD, Director, Office of Regulations

Beverly Chernaik, JD, Director, Office of RegulationsBeverly Chernaik, JD, Director, Office of Regulations

Beverly Chernaik is currently the Director of the Office of Regulations at the Center for Tobacco Products (CTP) of the Food and Drug Administration.  She was appointed to that position in April 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.  Ms. Chernaik leads CTP’s efforts to identify and prioritize regulations and guidances that will help the Center achieve its public health goals. 
 
Before taking on her current position at the Center for Tobacco Products, Ms. Chernaik was an attorney in FDA’s Office of the 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, 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.  She was the lead attorney in the negotiations for the first user fee program for medical devices and for the reauthorization of that program.  Ms. Chernaik has had extensive experience in the development, drafting, and review of regulations implementing new FDA legislative authorities, including the Medical Device Amendments of 1976, the Food and Drug Modernization Act, the Medical Device User Fee Amendments, and the Family Smoking Prevention and Tobacco Control Act.  She has received more than 40 awards for serving the agency with distinction.
 
Ms. Chernaik received her B.A., magna cum laude, from the University of Massachusetts in 1974, and her J.D., cum laude, from Suffolk University Law School in 1977, where she was Note Editor of the Suffolk University Law Review.