As regulatory frameworks for orphan medicinal products continue to evolve on both sides of the Atlantic, understanding the practical and strategic implications is increasingly important. On March 17th from 10:00 to 11:00 ET, Pinsent Masons and Hyman, Phelps & McNamara, P.C. are pleased to host a …
Hyman, Phelps & McNamara, P.C. (HPM) is hosting a complimentary webinar, titled “From Prototype to Approval: US Regulatory Strategy for MedTech Startups.” The webinar is scheduled for March 25, 2026 (11:00am to 12:00pm ET). Bringing a medical device from prototype to market requires more than innovation—it …
The American Conference Institute’s (ACI’s) Annual Paragraph IV Disputes Conference is scheduled to take place from April 21-22, 2026 at The Times Center, New York, NY. Join the nation’s most respected forum for pharmaceutical patent litigation as it returns for its 22nd edition. This is …
Controlled substances are necessary for the medical care of patients, but recent diversion by pharmacists, physicians, nurses and other healthcare professionals illustrates the vulnerability of hospitals. Hospitals that fail to provide effective controls and procedures to guard against theft and diversion of controlled substances pose …
The American Conference Institute’s (“ACI”) milestone 10th Anniversary edition of its Advanced Summit on Food Law, Compliance and Regulation is scheduled to take place from April 28–29, 2026 at the Hilton Chicago/Magnificent Mile Suites in Chicago, IL. Since ACI’s last summit, the food industry continues to …
The American Conference Institute’s (“ACI”) FDA Boot Camp returns March 25-26, 2026, at the New York City Bar, New York, NY. This foundational training brings together life sciences attorneys, in-house counsel, and compliance professionals to dissect FDA law, policy, and enforcement trends. What You’ll Gain: A clear …
The American Conference Institute’s (“ACI”) 13th Annual Legal, Regulatory & Compliance Forum on Cosmetics & Personal Care Products returns March 12-13, 2026 at the New York City Bar, New York, NY. The forum once again brings together the legal and regulatory leaders of the cosmetics …
Hyman, Phelps & McNamara, P.C. Director Kalie E. Richardson will be moderating a Food and Drug Law Institute webinar this coming Wednesday on Ensuring Effective Responses to FDA 483s and Warning Letters. This webinar will cover fundamental considerations for responding to FDA 483s and Warning …
Artificial Intelligence (“AI”) in the life sciences has moved from pilot to production, across discovery, trials, and post-market. With the EU AI Act taking effect, evolving FDA expectations, and looming litigation and enforcement risk, getting it right has never mattered more. Join the American Conference Institute …
We are proud to announce that Hyman, Phelps & McNamara, P.C. (HPM) has been named to the 2026 Best Law Firms® list, receiving top-tier recognition for our work in FDA Law. The firm earned: National Tier 1 – FDA Law Regional Tier 1, Washington, D.C. – FDA …
At this point in 2024, there were countless unknowns about how the medical device industry would be impacted in 2025. Did the year unfold as you expected? Did your company prepare for impacts to the foreign supply chain? Did you predict the government was going …
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 …
