Earlier this week, the U.S. Senate passed S. 1082, the “Food and Drug Administration Revitalization Act” (“FDARA”) by a vote of 93-1 (Sen. Bernie Sanders (I-VT) was the lone “nay” vote). The bill is an omnibus FDA reform and user fee package that, among other …
The Council for Entrepreneurial Development will hold a “MedTech” forum on June 6, 2007 in Research Triangle Park, NC to discuss FDA’s regulation of medical devices and device reimbursement under the Medicare program. HPM’s own Marc Shapiro will moderate the program. Jeff Gibbs and Kirk …
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 …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Carrie S. Martin has joined the firm as an associate. Ms. Martin earned a law degree with honors from The George Washington University Law School in 2004. She served as an Articles Editor for the …
A recent California case, In re CV Therapeutics, Inc. Securities Litigation, raised the question of whether, within the context of the attorney-client privilege, regulatory advice provided by food and drug attorneys qualifies as “legal” (protected) advice or “business” (generally not protected) advice. The court concluded …
