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10 Jan 2022, 4:59 am by Hyman Phelps McNamara
Hyman, Phelps & McNamara, P.C. is the largest dedicated FDA law firm, and we need attorneys to help our clients bring pharmaceutical drugs and medical devices to market. [read post]
21 Dec 2021, 2:16 am by Hyman Phelps McNamara
Hyman, Phelps & McNamara, P.C. is  pleased to announce that Adrienne Lenz will be speaking on Deciphering New and Proposed Regulatory Guidances For Medical Devices and Diagnostics at the Q1 Productions 4th Annual Life Science Regulatory Intelligence Virtual Event being held January 24-25, 2022. [read post]
29 Sep 2021, 4:59 pm by Hyman Phelps McNamara
Practice, Policy, and Procedure in the New World of Pharmaceutical Patent Validity Challenges” “The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena” Hyman, Phelps & McNamara, P.C. [read post]
23 Sep 2021, 1:37 am by Hyman Phelps McNamara
Hyman, Phelps & McNamara, P.C. is pleased to announce that Jeffrey Shapiro and Serra Schlanger will present at this year’s Food and Drug Law Institute virtual Advertising and Promotion for Medical Products Conference on October 13–15. [read post]
9 Aug 2021, 5:15 pm by Kurt R. Karst
Farquhar —On the heels of Genus Medical Technologies’ successful lawsuit against FDA—Genus was represented by Hyman, Phelps & McNamara PC—in both the District Court of D.C. and the Court of Appeals for the D.C. [read post]
26 Jul 2021, 12:00 am by Hyman Phelps McNamara
A distinguished cast of presenters will share their knowledge and provide critical insights on a host of topics, including (conference agenda here): The organization, jurisdiction, functions, and operations of FDA The essentials of the approval process for drugs and biologics, including: INDs, NDAs, BLAs, OTC Approval, the PMA process and the Expedited Approval Process Clinical trials for drugs and biologics Unique Considerations in the approval of combination products, companion diagnostics, and… [read post]
7 Jul 2021, 2:20 pm by Kurt R. Karst
  (Hyman, Phelps & McNamara helped represent JRC in this matter.) [read post]
6 Jul 2021, 3:38 pm by Kurt R. Karst
In a recent case that Hyman, Phelps & McNamara, P.C. and Upadhye Tang LLP filed against FDA in the D.C. [read post]
6 Jun 2021, 8:28 pm by Hyman Phelps McNamara
  Hyman, Phelps & McNamara, P.C. attorneys Sara Koblitz and Anne Walsh contributed to this year’s installment. [read post]
1 Jun 2021, 7:36 pm by Kurt R. Karst
  We at Hyman, Phelps & McNamara, P.C. include FDA among those we are eager to see in person again soon. [read post]
20 Apr 2021, 2:08 pm by Hyman Phelps McNamara
Hyman, Phelps & McNamara, P.C. and Analysis Group are partnering to host a two-hour timely, informative and free program to discuss current important legal perspectives and analytical trends concerning the Controlled Substances Act and the Drug Enforcement Administration. [read post]
16 Apr 2021, 5:42 am by Hyman Phelps McNamara
Hyman, Phelps & McNamara, P.C. seeks a 2nd to 4th year associate to join our team and work on a wide variety of FDA-related matters. [read post]