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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/
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/
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/
Decisions, Decisions, Decisions! Our Updated Labeling Carve-Out Citizen Petition Scorecard
16 May 2012, 12:45 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Issues Report to Congress on Findings and Recommendations of Rare and Neglected Tropical Disease Groups; Groups Report Strengths and Opportunities to Improve Regulatory Paradigms and Science
1 Sep 2011, 4:31 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Reports Detail FDA’s 505(q) Citizen Petition Response Track Record; Section 505(q) May Have Some Unintended Consequences, FDA Says (Part I)
24 Jan 2011, 4:27 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Rescinds Orphan Drug Exclusivity for Wilate; A First-of-its-Kind Decision
8 Aug 2012, 8:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
PTO Challenged After Denying a Patent Term Extension Based on First Commercial Marketing or Use Grounds
31 Jan 2012, 12:54 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Federal Circuit Rules That Hatch-Waxman “Safe Harbor” is Quite Broad in Dispute Over Enoxaparin Method Patent
7 Aug 2012, 7:43 pm 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. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA Grants Petition Requesting a “Superseding” 30-Month Stay for Generic HECTOROL
25 Oct 2010, 10:52 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Absolutely, Totally, and in All Other Ways Inconceivable? Nope, Says the Federal Circuit in YASMIN Hatch-Waxman Method Patent Litigation
18 Apr 2012, 7:28 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Subsequent ANDA Sponsor Says DETROL LA Patent Has Gotta Go; But Would a Final Court Decision Trigger 180-Day Exclusivity?
10 Feb 2011, 5:35 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Does a Subsequent Paragraph IV Filer Have a Legally Cognizable Interest in When a First-Filer’s 180-Day Exclusivity Period Begins for DJ Jurisdiction Purposes?
6 Oct 2010, 11:43 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Sends User Fee Pacts to Congress; Proposed Generic Drug User Fee Statute Includes Some Unique Provisions
18 Jan 2012, 1:55 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
GDUFA Negotiations Completed; Safety, Access, Transparency Are the Primary Aims of the New Program
22 Sep 2011, 1:44 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/