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“Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace
21 Apr 2024, 7:06 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3 . . . and PART 3½)
13 Mar 2024, 7:24 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)
29 Feb 2024, 5:17 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)
27 Feb 2024, 7:08 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA Knows Its Own Strength—and It Includes Concentration
26 Feb 2024, 2:26 am by Kurt R. Karst
Koblitz & Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
HP&M Counsel John Claud Provides Testimony to House Subcommittee on FDA Foreign Inspections
6 Feb 2024, 7:39 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House
24 Jan 2024, 9:11 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
ACI’s 42nd FDA Boot Camp – New York City Edition
24 Jan 2024, 2:48 am by Hyman Phelps McNamara
  Join our co-chairs Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Hyman, Phelps & McNamara, P.C. Takes Top Honors in Two Prestigious Categories in 2023 LMG Life Sciences Awards
6 Nov 2023, 4:51 pm by Hyman Phelps McNamara
Javitt, Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA
19 Sep 2023, 3:34 am by Kurt R. Karst
Koblitz & Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America
24 Aug 2023, 6:42 pm by Hyman Phelps McNamara
Gibbs – FDA Law Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
HP&M Attorneys Receive Accolades: Top Lawyer Under 40 and WWL: Life Sciences 2023 Global Elite Thought Leader
27 Jun 2023, 2:29 am by Hyman Phelps McNamara
HP&M’s Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
B-B-B-B-Bad to the Bone? The Brought Back BLOCKING Act: Better, But Still Bad for Business and Buyers
2 May 2023, 2:20 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review
30 Apr 2023, 8:00 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
ACI’s 40th FDA Boot Camp – March 22-23, 2023 (Virtual)
2 Jan 2023, 7:14 pm by Hyman Phelps McNamara
This year’s conference co-chairs include Stacy Cline Amin (Partner, Morrison Forester) and Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
HP&M Promotes James Valentine to Director
16 Oct 2022, 7:12 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act
10 Oct 2022, 6:51 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Here It Goes, Here It Goes, Here It Goes Again: The Build Back Better Act (Redux)
13 Jul 2022, 10:39 pm by Kurt R. Karst
Koblitz & Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements is Just Days Away
23 Jun 2022, 6:56 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA in the Multiverse of 180-Day Exclusivity Madness: Is an “Incursion” in the Cards for our “Exclusivity Earth-616”?
26 May 2022, 10:30 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/