Hyman, Phelps & McNamara, P.C. Director Jeff Shapiro will be moderating “Digital Health Session 1: Bonus Session – Regulation and Utilization of Digital Health in Clinical Trials” as part of the Food and Drug Law Institute’s Digital Health Conference on September 10. Jeff’s panel will …
Device Attorney HP&M seeks to add an associate to its thriving device practice. We assist medical device manufacturers with product development, FDA approval and clearance, and post-market compliance. Qualified candidates should have familiarity with premarket strategies, including: Investigation Device Exemption requirements Premarket Notifications (510(k) clearances) Premarket Approval Applications …
The American Conference Institute (“ACI”) is sponsoring its 14th Annual Paragraph IV Disputes Conference on October 6 – 7, 2020 (Eastern Daylight Time). Like a lot of conferences this year, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference. ACI’s Paragraph …
The American Conference Institute (“ACI”) is sponsoring its annual Food Law Conference on July 15, 2020. Like a lot of conferences this year, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference. ACI’s Food Law conference is a unique, …
The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The virtual conference is scheduled to take place on June 23-24, 2020. This “must-attend” event for legal, regulatory, and compliance stakeholders in …
Hyman, Phelps & McNamara, P.C. seeks to add a 1st to 4th year associate to its enforcement and litigation team. Our team investigates and defends against threatened enforcement actions by government prosecutors and regulators, including the FDA and DEA. Types of matters include: Representing clients in …
These are unsettling times as COVID-19 impacts our personal and professional lives, as well as those that we love. During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of the FDA Law Alert. This is the fifth …
On Wednesday, May 6, 2020, from 12:00pm-1:00pm (Eastern) the Maryland/Israel Development Center will hold a webinar, “Israeli COVID-19 Vaccine Developments.” The event will discuss how Israel has mobilized its scientific and technological talents to address COVID-19, and will feature the following speakers: Yaky Yanai, CEO of …
A month ago, we blogged on FDA’s emerging strategy of granting Emergency Use Authorizations (EUAs) for devices, drugs, and biologics that can be used to combat the spread of COVID‑19. Since then, FDA has begun granting EUAs, with more in the pipeline. In addition, the …
Genetics and genomics are becoming crucial to clinical care. As the “precision medicine” revolution spreads, cancer treatment, rare disease diagnosis, and cardiac care increasingly utilize genomics. Unfortunately, law and policy lag behind science, and the law governing genomics remains unclear – which means the time …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Karin Moore has become its newest Director. Drawing on her years of experience as a former general counsel to leading trade associations, Karin is an industry expert and thought leader in the areas of …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Richard Lewis has become its newest Senior Regulatory Device & Biologics Expert. Coming to us after more than 4 years at FDA, Richard worked in the Center for Biologics Evaluation and Research (CBER) and …
Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 35th iteration – is scheduled to take place from March 24- 25, 2020 at DoubleTree By Hilton Metropolitan, New York, NY. The conference is billed as the premier event to provide folks with …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Serra Schlanger will present at this year’s Drug Pricing Transparency Congress, to be held in Philadelphia, PA on March 30-31, 2020. This conference gathers stakeholders to examine the evolving landscape of state drug price reporting …
