Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add an experienced regulatory expert to our strong and busy team of non-attorney regulatory experts. Our team assists clients with a wide variety of quality and manufacturing regulatory topics for drugs and biologics. Types of matters include: Developing …
Hyman, Phelps & McNamara (HPM) marks its 45th Anniversary year by welcoming three accomplished professionals who reinforce the depth and breadth of the firm’s FDA and DEA practices. Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDA’s Center for Drug …
During the Regulatory Freeze Pending Review and the HHS Immediate Pause on Issuing Documents and Public Communications, our thoughts turned to the principles underlying the Freedom of Information Act (FOIA). As the DOJ FOIA Guide explains in its introduction: The United States Supreme Court has explained …
The confirmation hearings for Robert F. Kennedy, Jr. to lead the Department of Health and Human Services kick off at 10 am on January 29 and promise to have a packed agenda. With oversight over FDA, the Centers for Medicare & Medicaid Services, the National …
Hyman, Phelps & McNamara PC, (HPM), which will mark its 45th Anniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. Kalie E. Richardson has been promoted to Director. Mark Tobolowsky has been promoted to …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce that 16 of the Firm’s attorneys have been selected to the 2025 edition of The Best Lawyers in America®. Founding Director Paul M. Hyman has been rightfully chosen as a 2025 “Lawyer of the Year.” …
The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week. Several leading ladies in law at HPM attended the conference and, based on their …
Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add an experienced attorney (7+ years) to our government discount program and price reporting practice. Our ideal candidate will have significant substantive experience working with: Price calculation and reporting under the Medicaid Drug Rebate Program and the 340B …
Hyman, Phelps & McNamara, P.C. (HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable …
On April 29, 2024, FDA announced its finalization of the laboratory developed test (LDT) rule. The final rule will be published in the Federal Register on Monday May 6, 2024 (here). The final rule marks another milestone in the more than three decades long battle …
As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. Interest rates may be on the way down, which in turn may …
What do Gene Autry’s Rudolph the Red-Nosed Reindeer and FDLI have in common? Both are celebrating their 75th anniversaries in 2024. While “The Singing Cowboy” Gene Autry was busy in Los Angeles recording Rudolph the Red-Nosed Reindeer, The Food and Drug Law Institute (FDLI) founders were …
Hyman, Phelps & McNamara, P.C. (“HP&M”), the largest FDA-dedicated law firm, is pleased to announce that Julie Beitz, M.D. has joined the firm as a Principal Drug Regulatory Expert. Dr. Beitz served in leadership positions in FDA’s Center for Drug Evaluation and Research for nearly three …
Hyman, Phelps & McNamara, P.C. (HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Grizzel will oversee the marketing organization, with responsibility for …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA …
