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Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government
1 Oct 2024, 8:21 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
“If You’ve Got Legitimate Suspenders, Don’t Have an Unconstitutional Belt:” Federalist Society Panel’s Take on Jarkesy and the Preserve Access to Affordable Generics and Biosimilars Act
3 Dec 2024, 8:41 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA, Ahead of GDUFA II Enactment, Starts the Ball Rolling with Pre-Submission Facility Correspondence Guidance
20 Jun 2017, 7:34 pm by FDABlog HPM
By Kurt R. Karst – Although both the U.S. House of Representatives and U.S. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
ASBM Says Distinct USAN Names for Biosimilars are Needed
29 Nov 2012, 11:21 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees
27 Jun 2017, 9:00 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Decades Later, Congress Continues Debating the Preserve Access to Affordable Generics (and Biosimilars) Act; But will the Recent Jarkesy SCOTUS Decision Finally Put an End to the Insanity?
29 Aug 2024, 7:23 pm by Kurt R. Karst
By Kurt R. Karst & Michael D. [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/
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/
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/
FDA Law: You’re Invited . . . To a Dance Party! Will You Dance the Amgen Waltz, or the Sandoz Shuffle?
28 Apr 2015, 9:14 am by Dennis Crouch
Guest Post By Kurt R. Karst.  Mr. [read post]
Patently-O - https://patentlyo.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/
Endo Sues FDA; Seeks Court Orders for FDA Determinations on the Discontinuation of “Old” Opana® ER and With Respect to Approved and Pending ANDAs
2 Dec 2012, 3:28 pm by FDABlog HPM
By Kurt R. Karst –     Last Friday afternoon, Endo Pharmaceuticals Inc. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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. Karst & Michael D. Shumsky —On May 2nd, the U.S. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II
28 Jun 2017, 7:31 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Rules? Where We’re Going, We Don’t Need Rules: FDA Goes Back to the Future With Recent Hatch-Waxman Policy Shifts; What’s a Company to do?
2 Sep 2024, 5:52 pm by Kurt R. Karst
By Kurt R. Karst —Tell me doctor, where are we going this time? [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. Karst & Steven J. Gonzalez & Philip Won & Gail H. [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/
ACI’s 17th Annual Paragraph IV Disputes Conference (In-Person and Livestream)
14 Apr 2022, 10:49 am by Hyman Phelps McNamara
’s 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/
ACI’s 10th Anniversary Paragraph IV Disputes Master Symposium
24 Jul 2024, 6:54 pm by Hyman Phelps McNamara
’s Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/