Search for: "Hyman Phelps McNamara" Results 181 - 200 of 214
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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]
12 Aug 2010, 2:28 am by Duncan
Karst, Hyman, Phelps & McNamara, P.C., United States Klaus Kupka, Taylor Wessing, Germany David 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]
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]
22 Dec 2022, 12:44 am by Kurt R. Karst
  (Hyman, Phelps & McNamara, P.C., was co-counsel for the Judge Rotenberg Center in this litigation.) [read post]
30 Nov 2010, 8:35 am by Eric Turkewitz
He’s a newcomer to the blogosphere and well worth the read; Drug & Device Law: BigLaw firm Dechert has a group blog that focuses on the defense of, well, drug and device cases; FDA Law Blog: Another newcomer to the blogosphere, the firm of Hyman, Phelps & McNamara focuses on government regulation of the food and drug biz; Jackson on Consumer Class Action and Mass Torts: Another BigLaw entry, this by Russell Jackson at Skadden, Arps, Slate, Meagher &… [read post]
28 Apr 2007, 10:55 am
A recent entry in that area is the FDA Law Blog, hosted by some lawyers at Hyman Phelps & McNamara. [read post]
3 May 2011, 7:16 am by Zoe Tillman
Mylan was represented by Douglas Farquhar of Washington’s Hyman, Phelps & McNamara, who declined to comment when reached Monday evening. [read post]
12 Aug 2013, 9:30 pm by Kara Cheever
Michelle Butler, a lawyer with Hyman, Phelps & McNamara who filed a whitepaper with the FDA, argues that the bar for demonstrating clinical superiority is too high. [read post]
6 Nov 2007, 9:57 pm
Anonymous tentatively approved filer (with support from Sandoz and Apotex) The law firm of Hyman, Phelps & McNamara ("HPM") submitted a letter "on behalf of a company with a tentatively approved ANDA" for ramipril. [read post]
14 Oct 2012, 6:04 pm by Leland E. Beck
Ricardo Carvajal, of Hyman, Phelps & McNamara, points out that the Department of Justice, for the FDA, requested rehearing and rehearing en banc in R.J. [read post]
3 Aug 2022, 2:21 am by Kurt R. Karst
Gibbs, Hyman, Phelps & McNamara, Docket No. 92P-0405 (Aug. 12, 1998) (available here). [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]