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Benjamin Wolf practices in the area of food and drug law. Mr. Wolf advises food, dietary supplement, medical device, consumer product, and pharmaceutical clients regarding compliance with domestic and foreign regulations. His practice also includes providing state and federal legislative counsel to tobacco and e-vapor suppliers and manufacturers.
Prior to joining Keller and Heckman, Mr. Wolf worked for the Food and Drug Administration (FDA) as a regulatory counsel in the Center for Tobacco Products (CTP) and Office of Regulatory Affairs (ORA). In his role as a regulatory counsel, Mr. Wolf worked closely with CTP, ORA, the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) to develop and implement policies including tobacco compliance and enforcement, tobacco premarket review, medical device compliance and enforcement, device premarket, and device and combination products good manufacturing practice. This work touched upon areas including tobacco substantial equivalence (SE), premarket tobacco product applications (PMTAs), modified risk tobacco product applications (MRTPAs), investigational tobacco product applications (ITPAs), data integrity, medical device quality metrics, utilization of benefit and risk factors in determining appropriate FDA engagement for devices being marketed, laboratory developed tests (LDTs), and good manufacturing practice (GMPs) for medical devices and combination products.
Also while at the FDA, Mr. Wolf served as a reviewer of certain tobacco premarket applications and submissions; responded to Congressional, Government Accountability Office (GAO) and Office of Inspector General (OIG) inquiries; and trained in bioresearch monitoring for field investigators.
Mr. Wolf’s practice is benefited by his extensive background as a research and development engineer at a medical device company in Boston, Massachusetts. In that role, he gained experience in GMP compliance, preparing regulatory submissions and addressing FDA questions. He has executed numerous bench and animal studies to support regulatory filings.
Prior to law school Mr. Wolf completed graduate-level coursework in Aerospace and Mechanical Engineering at Boston University. While at George Washington University Law School, Mr. Wolf worked as a student attorney assisting clients with proceedings in the Vaccine Injury Compensation Program (VICP). His Student Note, written while serving as a member of the Federal Circuit Bar Journal (FCBJ) and regarding the VICP, was selected for publication as the best Student Note written for the FCBJ during the 2011-2012 academic year. Mr. Wolf was the recipient of the Henry R. Berger Award, awarded to one graduate annually for excellence in tort law.
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