Search for: "Hyman Phelps McNamara"
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9 Nov 2022, 3:39 pm
As we have done in the past for the initial and each quinquennial reauthorization of the drug and medical device user fee laws—in 1992, 1997, 2002, 2007, 2012, and 2017—Hyman, Phelps & McNamara, P.C. has prepared a detailed Summary and Analysis of FUFRA. [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]
10 Jan 2012, 5:21 pm
On December 2, 2011, Hyman, Phelps, & McNamara filed comments to the controversial Draft NDI Guidance requesting that it be withdrawn, consistent with the comments of the Alliance for Natural Health, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance – see our previous post here. [read post]
10 Mar 2024, 1:53 pm
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]
4 Mar 2024, 1:33 pm
Hyman, Phelps & McNamara, P.C. [read post]
8 Aug 2012, 4:30 am
” If you’re up for some light reading, the FDA Law Blog provides a link to a 75-page “summary” of all 11 titles of the law by the FDA powerhouse firm Hyman, Phelps & McNamara, which can also be found here. [read post]
12 Mar 2009, 11:16 pm
Levine: How to Survive in a Post-Preemption World," with Kurt Karst and John Fleder, both of Hyman, Phelps & McNamara. [read post]
22 May 2023, 9:52 pm
Hyman, Phelps & McNamara, P.C. [read post]
26 Sep 2023, 2:23 am
Non-compliant facilities face: Increased patient and employee health risks — in some cases even overdose deaths Multi-million-dollar settlements — and these amounts have been increasing each year Significant long-term compliance costs to meet the requirements of government settlement agreements Erosion of public trust and confidence in affected hospitals and pharmacies Unwanted local and national publicity Hyman, Phelps & McNamara (HP&M) invites… [read post]
2 Jan 2023, 7:14 pm
Karst (Director, Hyman, Phelps & McNamara P.C.). [read post]
16 Oct 2022, 7:12 pm
Karst —Hyman, Phelps & McNamara, P.C. [read post]
21 Oct 2009, 11:24 am
I hope you can join me, my colleague at Stoel Rives, Jere Webb, Alison Dennis from Burgerville, Roberta Anderson from Food Alliance and Ricardo Carvajal from Hyman Phelps and McNamara on November 3, at 9 am PST, noon EST, (live Twitter feed at #sustainlaw) for the next webinar as we discuss the following: Regulatory Traps – Current Regulatory Environment For Making Sustainable Claims and Standard-Setting Efforts Currently Underway, Avoiding… [read post]
10 Jun 2012, 5:53 pm
.), represented by Hyman, Phelps & McNamara, P.C., filed a food additive petition (Docket No. [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]
11 Mar 2010, 4:35 pm
Our colleagues from Hyman, Phelps & McNamara’s FDA Law Blog released an excellent post on this subject, so we will discuss the general findings and recommendations of the report here. [read post]
17 May 2022, 2:20 am
Hyman, Phelps & McNamara, P.C. [read post]
11 Jul 2012, 1:25 pm
Hyman, Phelps & McNamara, P.C. has prepared a detailed summary and analysis of FDASIA. [read post]
12 Mar 2023, 7:20 pm
Hyman, Phelps & McNamara, P.C. [read post]
4 Mar 2011, 5:11 am
We also thank our Hyman, Phelps & McNamara, P.C. colleagues for their time and dedication to writing interesting and informative posts. [read post]
