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.
•Feb 23, 2018 Keller and Heckman LLP Launches Audit and Inspection Program for Vapor and Tobacco Product Manufacturing Establishments
•Jan 09, 2018 FDA Extends Enforcement Discretion on Certain FSMA Provisions
•Sep 29, 2017 FDA Extends U.S. Tobacco Product Manufacturing Establishment Registration and Product Listing Deadline to October 12, 2017 to Accommodate Technical Issues with FURLS
•Sep 18, 2017 New FDA Guidance Document on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments Published
•Jul 31, 2017 FDA's New Tobacco Strategy: What Does It Mean for Your Vape Business?
•May 02, 2017 FDA Delays Upcoming Deeming Compliance Deadlines by Three Months; Sign Up for our FDA Compliance Webinar on May 9, 2017
•Jan 27, 2017 FDA Finalizes New Rule Clarifying When a Tobacco Product is Actually a Medical Product
•May 09, 2017 Webinar: Deeming Regulation Compliance: FDA Registration and Product Listing, Health Document Submissions and Ingredient Reporting for E-Liquids and Vapor Devices
•May 03, 2018 Azim Chowdhury, Eric Gotting, and Ben Wolf to Attend FDLI Annual Conference
•Feb 06, 2018 Keller and Heckman LLP Announces its Newest Law Blog for Vapor, Tobacco and Reduced-Harm Product Companies: The Continuum of Risk
•Oct 02, 2017 Keller and Heckman's Tobacco and E-Vapor Practice Mentioned in Vaping Post Article FDA Announces Another Extension for Manufacturers Product Listing
•Feb 02, 2017 Vape Mentors E-Vapor Law Symposium
•American Bar Association
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