Search for: "Kurt R. Karst" Results 261 - 280 of 363
Sorted by Relevance | Sort by Date
RSS Subscribe: 20 results | 100 results
New Jersey District Court Denies Preliminary Injunction Motion in Generic CARBATROL Pre-MMA 180-Day Exclusivity Case; An Appeal Quickly Follows
7 Jul 2011, 3:38 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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. [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. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Generic Drug Industry Headed for a “180-Day Exclusivity Cliff”
16 Nov 2010, 2:43 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
GAO Issues Report on Non-Inferiority Studies; Finds No Evidence of “Biocreep,” But More Conservative Use of Such Studies to Support Approval
30 Aug 2010, 11:53 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Federal Circuit Affirms Two District Court Decisions Concerning PTE Availability; Decisions Embrace an “Active Ingredient” Approach to PTEs
10 May 2010, 10:37 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Outstanding Pre-FDAAA Citizen Petition Causes FDA to Rule Against 180-Day Exclusivity Forfeiture for Generic SKELAXIN
14 May 2010, 4:00 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Sanofi Seeks Summary Judgment in Generic LOVENOX Dispute; Administrative Record Highlights Disagreements at FDA Over Generic Approval
14 Dec 2010, 7:06 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
A Trio of Reports Discuss the Benefits of the Pediatric “Carrot and Stick” Statutes, the Orphan Drug Act, and Hatch-Waxman
6 Mar 2012, 4:19 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
PTO Clarifies PTE Availability in Post-PhotoCure and Post-Ortho-McNeil World; PhotoCure Takes Advantage of . . . . PhotoCure
10 Nov 2010, 6:22 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Sturm und Drang: The TPP Agreement and Biologics Exclusivity
7 Aug 2011, 5:31 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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/
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 1)
27 Feb 2024, 7:08 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/
FDA Issues Final 505(q) Citizen Petition Guidance, Says Certification/Verification Statement Accuracy is Paramount
9 Jun 2011, 12:54 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA is Sued Again Over Pre-MMA 180-Day Exclusivity; This Time the Drug is Generic ACTOS
15 Aug 2012, 11:02 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Petitioned on 180-Day Exclusivity Forfeiture for Tentative Approvals that Occur on the 30-Month ANDA Submission Anniversary Date
27 Jun 2012, 5:38 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
D.C. District Court Denies Preliminary Injunction In Generic SEROQUEL Litigation; Dismisses "Premature" Lawsuit Without Prejudice
26 Mar 2012, 1:43 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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/