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1 May 2024, 6:55 pm
Hyman, Phelps & McNamara, P.C. proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. [read post]
26 Mar 2024, 2:53 am
Hyman, Phelps & McNamara, P.C. [read post]
19 Mar 2024, 7:54 pm
Hyman, Phelps & McNamara, P.C. [read post]
11 Mar 2024, 7:32 pm
FDA has gone so far as to rescinded at least one 510(k) based on its determination that allegedly unreliable data have been submitted, even in the case where discrepancies in the data were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]
4 Mar 2024, 1:33 pm
Hyman, Phelps & McNamara, P.C. [read post]
26 Feb 2024, 6:52 pm
Hyman, Phelps & McNamara, P.C. [read post]
19 Feb 2024, 5:25 pm
Hyman, Phelps & McNamara, P.C. [read post]
6 Feb 2024, 7:39 pm
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
Having previously worked at HP&M, Sara recently rejoined the firm to assist clients with regulatory licensing services. [read post]
24 Jan 2024, 2:48 am
Karst (Director, Hyman, Phelps & McNamara, P.C.) and Stacy Cline Amin (Partner, Morrison & Foerster (Former Chief Counsel, U.S. [read post]
11 Jan 2024, 7:22 pm
Two Hyman, Phelps & McNamara, P.C. [read post]
21 Dec 2023, 7:36 pm
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,… [read post]
21 Dec 2023, 12:44 am
By Hyman, Phelps & McNamara, P.C. [read post]
6 Dec 2023, 9:36 pm
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]
30 Nov 2023, 8:44 pm
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]
15 Nov 2023, 1:57 am
Hyman, Phelps & McNamara, P.C. [read post]
13 Nov 2023, 3:15 am
Program highlights include: Spotlight on FDA’s Newly Proposed ACNU Rule Updates on Monograph Reform Implementation Advertising, Labeling and Claims Substantiation Essentials Exploring the Recent Wave of Rx-OTC Drug Switches Hyman, Phelps & McNamara, P.C. [read post]
6 Nov 2023, 4:51 pm
About Hyman, Phelps & McNamara Hyman, Phelps & McNamara, P.C. is the largest dedicated food and drug law firm in the country. [read post]
5 Nov 2023, 7:32 pm
Philip Won, of Hyman, Phelps & McNamara, P.C. [read post]
10 Oct 2023, 8:46 pm
Hyman, Phelps & McNamara, P.C. [read post]