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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/
A New Book on Hatch-Waxman – Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer
25 Sep 2024, 7:07 pm by Kurt R. Karst
By 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. Karst —Hyman, Phelps & McNamara, P.C. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
New Report on Patent Litigation Settlements Says that they are Critically Necessary to Ensure Prompt Generic and Biosimilar Market Entry
26 Jun 2025, 7:27 am by Kurt R. Karst
By 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/
After a Hiatus, the BLOCKING Act is Back!
11 Dec 2024, 10:38 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Former DEA Administrators Weigh in on Marijuana Rescheduling
1 Jul 2024, 2:54 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/
The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs
8 Apr 2025, 5:10 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
A New Report Takes an Evidence-Based Approach to Analyzing the BLOCKING Act
25 May 2022, 12:00 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
The Greatest Trick the Devil Ever Pulled was Convincing the World He Didn’t Exist: Senate Judiciary Set to Mark-Up Patent Reform Bills that Could Significantly Affect Hatch-Waxman and the BPCIA
15 Sep 2024, 4:50 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.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
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA, in a RARE Act, Takes To Lobbying for a Change to the Orphan Drug Act
17 May 2022, 7:18 am by Kurt R. Karst
By Kurt R. Karst —We’re in the midst of UFA (User Fee Act) season! [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/
“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/
The Preserve Access to Affordable Generics and Biosimilars Act: It’s Back! And Bigger and Bolder than Before!
31 Mar 2025, 3:50 pm by Kurt R. Karst
By Kurt R. Karst —Last week, U.S. [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/
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/
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. Karst —Earlier this week, we posted Part 1 of our three-part series on U.S. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
The Preserve Access to Affordable Generics and Biosimilars Act: It’s Back! And Bigger and Bolder than Before!
2 Apr 2025, 1:54 pm by Kurt R. Karst
By Kurt R. Karst —Last week, U.S. [read post]
FDA Law Blog - https://www.thefdalawblog.com/