Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce that Steven Gonzalez has been promoted to Counsel. Steven joined the firm in 2022 and has quickly become a trusted advisor to clients navigating complex FDA regulatory and compliance matters. His practice focuses on advising pharmaceutical …
Hyman, Phelps & McNamara, P.C. (HPM) is hosting a complimentary webinar, titled “Medical Device Update, 2025 Year in Review.” The webinar is scheduled for December 10, 2025 (11:00am to 12:00pm ET). Don’t miss this essential briefing. Our experts will unpack the year’s top FDA regulatory changes, …
Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce that Fabiola Cervantes-Gomez, Ph.D. has joined the firm as a CMC Regulatory Expert. Dr. Cervantes-Gomez brings over eight years of experience from the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), …
The legal and regulatory landscape for controlled substances is in flux – telehealth prescribing rules have been extended to December 31, 2025, the new “HALT Fentanyl Act” heads to President Trump’s desk, all while recent opioid settlements signal sharper enforcement. Against this backdrop, the American …
The American Conference Institute’s (ACI’s) Pharma & Biotech Patent Litigation USA forum is scheduled to take place from October 14-15, 2025 at 3 Times Square in New York, NY. Billed as “the new US Gold Standard event for pharma and biotech patent litigation,” ACI’s Forum …
The American Conference Institute’s (ACI’s) virtual 5th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 14-30, 2025 (Eastern Standard Time). The virtual training series is specifically designed for attorneys, regulatory affairs professionals, and industry executives …
Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce speakers for the program we are co-hosting with Freshfields geared toward early-stage biotech and medtech companies. This program will be a half-day, in-person event at Freshfields’ Silicon Valley office on Wednesday September 10, 2025. HPM’s Michelle …
With great sadness, we announce that our colleague and friend Tom Scarlett passed away on August 20, 2025, at the age of 82. Tom was a great lawyer, a recognized leader of the food and drug bar, and an unexcelled teacher and inspiration to all …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce that 16 of our attorneys have been recognized in the 2026 edition of The Best Lawyers in America®. This recognition reflects the depth of our team’s experience and our ongoing commitment to excellence in FDA law, …
Karla Palmer and Andrew Hull will be presenting at this year’s Controlled Substances and State Regulatory Conference to be held in Savannah, GA, from September 3-5. Karla Palmer will be presenting on suspicious order monitoring and customer due diligence requirements for manufacturers and distributors as …
Hyman, Phelps & McNamara, P.C.’s John Gilbert will be speaking at the Demand Forecasting for Controlled Substances Hybrid Public Meeting sponsored by the Reagan-Udall Foundation for the FDA, Washington, DC. on August 27, 2025. The meeting is from 2-5pm (eastern) and includes both in-person and …
Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce a program that we are co-hosting with Freshfields geared toward early-stage biotech and medtech companies. This program will be a half-day, in-person event at Freshfields’ Silicon Valley office on Wednesday September 10, 2025, and will feature …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Peter “Pete” Dickos has joined the firm as Counsel. Pete brings nearly a decade of high-level government experience to HP&M’s Enforcement and Litigation practice, with a particular focus on complex regulatory and litigation challenges involving …
As we have previously covered, FDA has long been on the receiving end of criticism about its lagging foreign inspection program. The focus of the criticism has been that simply not enough foreign inspections are occurring at all and, when they do, they have historically …
The American Conference Institute’s 3rd Annual West Coast Forum on Legal, Regulatory, and Compliance for Cosmetics & Personal Care Products is scheduled to take place from October 8-9, 2025 in Santa Monica, California. The conference is the premier event on cosmetics and personal care products, where industry …
