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8 Sep 2011, 12:26 pm
In late July, Hyman, Phelps & McNamara, P.C. filed a request for a one-year comment period to allow affected businesses adequate time to respond to the lengthy and controversial draft guidance (see our previous post here). [read post]
2 Aug 2011, 11:32 am
Hyman, Phelps & McNamara, P.C. [read post]
27 Apr 2012, 7:44 am
Hyman, Phelps & McNamara, P.C. [read post]
31 Mar 2025, 7:35 pm
Laposata were represented by a team at Hyman, Phelps & McNamara, P.C., including Directors Michael Shumsky, Jeff Gibbs, Allyson Mullen, and Sara Koblitz, and Associates Steven Gonzalez and Sarah Wicks. [read post]
24 Mar 2011, 10:12 am
Hyman, Phelps & McNamara, P.C. [read post]
4 Sep 2024, 6:10 pm
Hyman, Phelps & McNamara, P.C. [read post]
4 May 2022, 8:26 pm
Hyman, Phelps & McNamara, P.C. is pleased to announce that Sophia Gaulkin will be speaking on an expert panel at the 20th Advanced Summit on Life Sciences Patents, which is being held virtually and in-person in New York City on June 2-3, 2022. [read post]
3 May 2023, 2:20 am
Hyman, Phelps & McNamara, P.C. [read post]
31 May 2022, 7:33 pm
Hyman, Phelps & McNamara, P.C. [read post]
24 Aug 2023, 6:42 pm
Hyman, Phelps & McNamara, P.C. [read post]
15 Nov 2023, 1:57 am
Hyman, Phelps & McNamara, P.C. [read post]
19 Mar 2023, 4:38 pm
Hyman, Phelps & McNamara, P.C. [read post]
15 Sep 2023, 3:44 am
Hyman, Phelps & McNamara, P.C. [read post]
11 Jan 2011, 1:13 pm
Hyman, Phelps & McNamara, P.C. [read post]
16 Oct 2022, 7:12 pm
Karst —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]
14 Apr 2022, 10:49 am
Over the course of two days, this event will provide impactful and practical programming all geared towards assessing the implications and imprimaturs of court cases, legislation, and industry behaviors which affect the patent endgame and the pursuit of related profits. 2022 agenda highlights include: The Viability of Written Description as a Compelling Invalidity Defense Clarity On What Satisfies Section 1400(b)’s Venue Requirements in the Hatch-Waxman Context Whether a Skinny Label… [read post]
15 May 2024, 3:53 am
EDT, Thursday, May 16, as Hyman, Phelps & McNamara, P.C. attorneys Gail H. [read post]
5 Feb 2012, 3:08 pm
Among other notable provisions, the proposed regulation would: Require states to convert to an actual acquisition cost basis for Medicaid prescription drug payment Expand the MDRP to the U.S. territories Apply a statutory alternative rebate for line extensions of oral solid dosage form innovator drugs, not only to new formulations, but new indications, combination products, and products marketed by companies independent of the company marketing the original drug Limit wholesaler sales… [read post]
29 Jan 2023, 6:09 pm
The analysis was prepared for Pharma Conference’s conference on February 8 and 9 in San Diego (“Current Hot GMP Topics”), linked here, where Hyman, Phelps & McNamara, P.C., Director Doug Farquhar will be presenting on three areas: enforcement areas of primary concern, the conduct of internal investigations, and contacting FDA about inspections. [read post]
