Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce the publication of its FDA Deskbook, incorporating more than a century of experience of HP&M’s attorneys from positions in the government and regulated industry. The FDA Deskbook provides a comprehensive resource that details the ins-and-outs of compliance and enforcement issues affecting FDA-regulated products. The book features chapters on each regulated product area, as well as hot-button issues like advertising and promotion, fraud and abuse, and internal investigations.
On April 27, 2016, at 1:00 pm Eastern, HP&M attorneys Jennifer D. Newberger, Jennifer M. Thomas, and Anne K. Walsh, will reference key sections from the book as they walk through a case study of a scenario facing a hypothetical medical device company (although the issues apply to any FDA-regulated entity) as it attempts to comply with FDA’s regulations and to respond to potential enforcement action when it fails to meet those requirements. The panel will:
- outline how a company (not product-specific) should behave during an FDA inspection;
- discuss best practices for responding to a contemporaneous whistleblower allegation and corresponding internal investigation; and
- evaluate ramifications of potential enforcement activities, including administrative, civil and criminal actions against it.
Register for this webinar here. Participants will receive a copy of Chapters 11 (Devices: Medical Device Reports) and 20 (Internal Investigations) from the book. Participants in this One-Hour Briefing are entitled to a 35% discount off the cover price of the book, which can be purchased here.