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Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice
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. With regulations varying significantly from one state to another, companies in these sectors often find themselves immersed in a labyrinth of compliance requirements. Some of the services HP&M offers include: comprehensive regulatory… [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Knock Knock. Who’s There? (or Quién es? or Qui est-ce? or Wer ist es?) Surprise, it’s FDA!
8 May 2025, 5:58 pm by Kurt R. Karst
In 2024, Hyman, Phelps & McNamara, P.C. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA Approval of New Therapy, Duvyzat, for Duchenne Muscular Dystrophy Represents Several Meaningful Firsts
26 Mar 2024, 2:53 am by Kurt R. Karst
  Hyman, Phelps & McNamara, P.C. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Our Space On The Web
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]
Drug and Device Law - http://druganddevicelaw.blogspot.com/
HP&M Files Comments Opposing FDA’s Proposed LDT Rule
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 [read post]
FDA Law Blog - https://www.thefdalawblog.com/
A Historic Day in Drug Development: FDA Approves Amylyx’s Drug to Treat ALS, Demonstrating FDA’s Application of Appropriate Flexibility in Rare Diseases
29 Sep 2022, 5:56 pm by Kurt R. Karst
  Hyman, Phelps & McNamara, P.C. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA's Request for Comments on Ramipril 180-day Exclusivity Draws Letters from Eight Generic Companies
6 Nov 2007, 9:57 pm
Anonymous tentatively approved filer (with support from Sandoz and Apotex) The law firm of Hyman, Phelps [read post]
Orange Book Blog - http://www.orangebookblog.com/
FDA Clarifies the Orphan Drug Act
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 [read post]
RegBlog - https://www.theregreview.org/
Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine
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]
FDA Law Blog - https://www.thefdalawblog.com/
Food Safety and Inspection Service leadership meets with public, industry representatives
23 Jul 2024, 9:04 pm by Dan Flynn
Poultry and Egg Association Randy Green, Watson Green, LLC Riette Van Laack, Hyman, Phelps & [read post]
Food Safety News - http://www.foodsafetynews.com/
Nine HPMers Chosen to Participate in 2024 FDLI Committees; FDLI Undergoes a Make-over
21 Dec 2023, 7:36 pm by Hyman Phelps McNamara
with food, drugs, cosmetics, medical devices, and other health-related products. 2024 brings a host of Hyman [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FSIS may not be blowing doors off, but they are open to large meetings with outsiders
8 Jul 2019, 9:05 pm by Dan Flynn
Eisenbeiser, Food Marketing Institute Betsy Booren, Grocery Manufacturers Association Riette van Laack, Hyman [read post]
Food Safety News - http://www.foodsafetynews.com/
Execs Convicted in First-Ever Consumer Product Safety Reporting Prosecution
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 [read post]
The D & O Diary - http://www.dandodiary.com/
Happy 40th Anniversary Hatch-Waxman! We’re Celebrating By Providing Access to a New Archive
23 Sep 2024, 6:53 pm by Kurt R. Karst
; On October 4, 2000, a second Citizen Petition (FDA Legacy Docket No. 2000P-1556) was submitted by Hyman [read post]
FDA Law Blog - https://www.thefdalawblog.com/
At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub
18 Jul 2024, 5:49 am by Kurt R. Karst
advocacy by the rare disease community for a Rare Disease Center of Excellence that was first proposed by Hyman [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument
20 Feb 2025, 1:11 pm by Kurt R. Karst
first said it could regulate LDTs, we now wait to see if the court will allow the rule to stand. [1] Hyman [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Bad Labs! Bad Labs? Whatcha Gonna Do?
11 Mar 2024, 7:32 pm by Kurt R. Karst
review of the submission and subsequently explained as a simple mistake (Stay of Action Petition from Hyman [read post]
FDA Law Blog - https://www.thefdalawblog.com/
It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs
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]
FDA Law Blog - https://www.thefdalawblog.com/
Stakeholders and lobbyists leave tracks at FSIS during October
10 Dec 2018, 9:05 pm by Dan Flynn
Smithfield Hiroko Bray, Smithfield Susan Finstad, Tyson Foods Kimberly Rice, US Foods Riette van Laack, Hyman [read post]
Food Safety News - http://www.foodsafetynews.com/
Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development
10 Nov 2024, 6:24 pm by Kurt R. Karst
We at Hyman, Phelps & McNamara congratulate the seven FY2024 Clinical Trials Grants Program Awardees [read post]
FDA Law Blog - https://www.thefdalawblog.com/