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Betelgeuse, Betelgeuse, Betelgeuse! The ANDA “RLD Theory of Liability” Rears Its Ugly Head
27 Oct 2011, 2:42 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/
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/
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/
FDA Proposes Generic Drug User Fee System and Performance Goals
7 Dec 2011, 7:25 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 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/
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/
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 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/
Nonprofit Groups Prevail in Lawsuit Against FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal Feed
27 Mar 2012, 1:09 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/
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/
A Flurry of Generic Drug Labeling Carve-Out Citizen Petitions; Scorecard Updated
3 Oct 2011, 8:01 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/
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/
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/
Office of Orphan Products Development SOPP Clarifies Orphan Drug Designation Policies
16 Oct 2011, 5:22 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
A 505(b)(2) NDA in Search of a Basis for Submission and Approval; the Curious Case of Morphine Sulfate Oral Solution
21 Jun 2012, 6:52 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/