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 conference is scheduled to take place at the InterContinental New York Times Square in New York, New York from June …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate. A demonstrated interest in food and drug law and regulation is preferred; strong research and writing skills are required. Compensation is competitive and commensurate …
The Food and Drug Law Institute (FDLI) is holding a conference devoted to digital health regulatory issues: Medical Devices: FDA Regulation in the Era of Technology and Innovation. Hyman, Phelps & McNamara’s Jeffrey K. Shapiro is the Chair. The conference will be held in South …
Spring is here! How do we know? Is it the cherry blossoms starting to bloom in Washington, DC? Is it the daffodils emerging from hibernation? No – we know it’s Spring because the annual American Conference Institute (“ACI”) “Paragraph IV Disputes” conference is right around …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 33rd iteration – is scheduled to take place from March 25-27, 2019, at the Park Lane Hotel in New York, NY. The conference is billed as the premier event to provide folks …
Hyman, Phelps & McNamara, P.C. (HP&M) is proud to announce that two associates, Serra Schlanger and Rachael Hunt, will be hosting a program on telemedicine for FDLI’s New to Food and Drug Law Group (NFDL). Telemedicine: Key Issues to Consider When Advising Clients, will take place …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Michael Shumsky has become its newest Director. Mike joined HP&M in February 2019 after nearly 15 years at Kirkland & Ellis LLP, where he played a key role in developing that firm’s FDA and …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne Walsh will present at this year’s Pharmacovigilance & Drug Safety: Risk Management & Regulatory Compliance Conference, to be held in Arlington, VA on March 12-13, 2019. The focus of her presentation is on post-market …
Next Thursday, February 7, the Food and Drug Law Institute will conduct a webinar entitled, “Patient Assistance Programs, Recent Enforcement and Best Practices.” The webinar will cover the various forms of patient assistance programs, the legal authorities that apply to them, recent enforcement actions, best …
CBI is holding its Fourth Edition Drug Pricing Transparency Congress on March 25-26, 2019 in Philadelphia, Pennsylvania. This program convenes stakeholders to discuss how the future of drug pricing transparency regulations will impact commercialization, reimbursement, pricing, and compliance practices. Given the novelty and complexity of …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …
Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce Allyson B. Mullen has become its newest Director. Allyson joined HPM in June 2013. Since that time, her years of service have made significant contributions to the firm and its clients. Prior to joining HPM, Allyson served …
The Food and Drug Law Institute’s (“FDLI”) Drug Quality and Security Act (“DQSA”) conference is just a few weeks away, and spaces are going fast! The conference will be held on November 15, 2017, in Washington, D.C. Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks an attorney to work with our drug development team. The attorney will assist our clients secure FDA approval for new drugs by leveraging our legal expertise of the approval …
On September 26, 2017, FDA combined and finalized two Draft Guidance documents first issued in 2011 that set forth the Agency’s approach to classifying products as “drugs” or “devices” under the FDC Act § 201. In doing so, FDA trimmed significant portions of both Draft …
