HPM Announces New Director

Hyman, Phelps & McNamara, P.C. is very pleased to announce that Jeffrey K. Shapiro has joined the firm as a director. Prior to joining the firm, Mr. Shapiro was a partner at Hogan & Hartson. Mr. Shapiro’s practice focuses primarily on assisting medical device and diagnostic manufacturers in complying with FDA regulatory requirements. Mr. Shapiro assists clients with obtaining premarket clearance or approval and compliance with postmarket requirements, such as labeling and advertising, the quality system regulation, adverse event reporting requirements, the regulation of in vitro diagnostic assays and analyte specific reagents, and responding to Form 483s and Warning Letters. He has extensive experience in FDA regulatory aspects of mergers and acquisitions, supplier contracts, and filings with the U.S. Securities and Exchange Commission. Mr. Shapiro frequently advises clients in combination product and product jurisdiction matters. For many years, he has assisted clients in addressing FDA’s evolving regulation of human and cellular based tissue products, along with state licensure requirements in that area. Mr. Shapiro is the co-editor of “Promotion of Biomedical Products,” a textbook on FDA’s regulation of promotion and advertising, and is also the co-author of the book, “Combination Products: How to Develop the Optimal Strategic Path for Approval.” He has authored numerous articles.