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ULTRA Bill Introduced in the House; Legislation Seeks to Permit Broader Use of Scientific Data to Support Surrogate Endpoints for “Ultra Orphan” Drug Approvals
2 Jan 2012, 6:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Legislation to Ban Authorized Generics During 180-Day Exclusivity Period Makes a Comeback in Congress
21 Feb 2011, 1:04 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA is Sued Over Product Designation Determination; Lawsuit Seeks Device Declaration and to Vacate FDA’s Drug Findings
30 Jun 2011, 1:45 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
180-Day Exclusivity – From Abacavir Sulfate to Zolpidem Tartrate
10 Aug 2010, 8:41 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
DC District Court Denies Sanofi Summary Judgment Motion in Generic ELOXATIN Case; Refuses to Reinstate 30-Month Stay on ANDA Approvals
28 Jul 2010, 7:53 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
A Not So Sweet 16 for FDA and PDUFA!
21 Apr 2010, 5:33 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
NORD Chair/HP&M Director Presents Opening Testimony at First Ever FDA Orphan Drug Hearing
30 Jun 2010, 10:15 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
CIPRO Patent Settlement Case is Appealed to the California Court of Appeal
20 May 2010, 7:30 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
D.C. Circuit Affirms District Court Ruling Concerning Losartan 180-Day Exclusivity Forfeiture Issue
6 Jul 2010, 11:03 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Itch is Scratched – FDA Denies XYZAL Carve-Out Petition; Another Precedent Added to the Generic Drug Labeling Carve-Out Citizen Petition Scorecard
24 Feb 2011, 1:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
NRDC Sues FDA for Failing to Take Action on Triclosan and Triclocarban
3 Aug 2010, 10:59 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Other Shoe Drops . . . . Sanofi Sues FDA Over Generic LOVENOX Approval
27 Jul 2010, 4:55 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Sen. Kerry Introduces ANGIOMAX PTE Amendment to Tax Extenders Act of 2009
27 May 2010, 12:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
District Court Denies Apotex Declaratory Judgment Motion on Generic ARICEPT; Does Not Accept “Prompt Launch” and “Indefinite Delay” Jurisdiction Theories
1 Sep 2010, 6:49 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
MDCO Prevails in ANGIOMAX PTE Case – District Court Grants Summary Judgment; Will the PTO Appeal?
3 Aug 2010, 1:57 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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/
ACI’s FDA Boot Camp Conference
19 Jan 2012, 7:44 pm by FDABlog HPM
’s Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
HP&M Attorney to Speak at CBI Paragraph IV Disputes Conference
5 Oct 2010, 10:49 am by FDABlog HPM
’s Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Applicant Claims PTE Eligibility Based on PhotoCure Dicta; A Set-up to a Court Challenge?
14 Nov 2010, 5:16 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Will the Hatch-Waxman Lock be Sprung in 2012?
7 Nov 2011, 1:07 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/