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19 May 2024, 5:49 pm by Kurt R. Karst
Joni Rutter, Director of the National Center for Advancing Translational Sciences, and Hyman, Phelps & McNamara’s own Frank Sasinowski who also serves as the Vice Chair of the Board for ELF. [read post]
1 May 2024, 6:55 pm by Hyman Phelps McNamara
Hyman, Phelps & McNamara, P.C. proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. [read post]
11 Mar 2024, 7:32 pm by Kurt R. Karst
  FDA has gone so far as to rescinded at least one 510(k) based on its determination that allegedly unreliable data have been submitted, even in the case where discrepancies in the data were obvious and not caught during FDA’s own review of the submission and subsequently explained as a simple mistake (Stay of Action Petition from Hyman, Phelps & McNamara, P.C. [read post]
10 Mar 2024, 1:53 pm by Hyman Phelps McNamara
Hyman, Phelps & McNamara Director Larry Houck will participate as a panelist focusing on this timely topic at the Food and Drug Law Institute’s (“FDLI’s”) Legal and Practical Issues in Cannabis Regulation Conference next month. [read post]
6 Feb 2024, 7:39 pm by Kurt R. Karst
Karst —The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations invited Hyman, Phelps & McNamara, P.C. [read post]
5 Feb 2024, 6:40 pm by Hyman Phelps McNamara
HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. [read post]
24 Jan 2024, 2:48 am by Hyman Phelps McNamara
Karst (Director, Hyman, Phelps & McNamara, P.C.) and Stacy Cline Amin (Partner, Morrison & Foerster (Former Chief Counsel, U.S. [read post]
21 Dec 2023, 7:36 pm by Hyman Phelps McNamara
  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 hard at work in Washington forming the association that still serves as the platform for discussing complex legal and regulatory issues associated with food, drugs, cosmetics, medical devices, and other health-related products. 2024 brings a host of Hyman, Phelps & McNamara, P.C. [read post]
6 Dec 2023, 9:36 pm by Kurt R. Karst
Javitt —On Monday, Hyman, Phelps & McNamara, P.C. filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. [read post]
4 Dec 2023, 8:33 am by Kevin LaCroix
The Hyman, Phelps, & McNamara law firm’s November 28, 2023 memo about the prosecution can be found here. [read post]
30 Nov 2023, 8:44 pm by Hyman Phelps McNamara
The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. [read post]