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GAO Says FDA Needs to do More to Address “Economic Adulteration”
27 Nov 2011, 12:08 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Report Predicts Tough Road Ahead for Some Generics After Federal Circuit Patent Use Code Decisions
3 Sep 2010, 11:42 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New Study Examines Citizen Petitions; Concludes that Petitions are on the Rise and that 505(q) Has Been Unsuccessful
17 Jun 2012, 5:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Snowmageddon, a Government Shutdown, and Other Acts of Nature (Mother or Human) – What are the Effects on FDA Approval Decision Deadlines?
1 Mar 2011, 1:32 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Burr Amendment to Senate FDA Approps Bill Seeks FDA Approval Time Transparency
2 Nov 2011, 10:14 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Last-Ditch Effort to Jettison “The Dog Ate My Homework Act” from the America Invents Act Fails
8 Sep 2011, 8:10 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Efforts to Obtain a PTE for ANGIOMAX Patent Continue as the U.S. House Passes an Amendment to the America Invents Act in “After Business Hours” Vote
28 Jun 2011, 2:03 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
District Court Says “Shall” Means “Must” in Challenge to PTO Denial of Interim Patent Term Extension
25 Jul 2011, 11:57 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Seeking a Second Bite at the Apple? Lannett Petitions FDA on the “Grandfather” Status of Morphine Sulfate
20 Feb 2012, 5:56 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Is Another Challenge to the PTO’s PTE “Product” Interpretation Looming?
3 Jun 2010, 5:42 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace
21 Apr 2024, 7:06 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Happy 40th Anniversary Hatch-Waxman! We’re Celebrating By Providing Access to a New Archive
23 Sep 2024, 6:53 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA Sued by Animal Rights Advocates and Ear (Holistic) Candle Advocates
14 Apr 2010, 12:05 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs
8 Apr 2025, 5:10 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
ViroPharma Sues FDA Over Generic VANCOCIN; Alleges that FDA Violated the APA in Effectively Amending Bioequivalence Regulations
13 Sep 2010, 11:02 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Senator Brownback Introduces the Creating Hope Act of 2010; Bill Would Change the Priority Review Voucher Program and Extend it to Applications for Rare Pediatric Diseases
5 Aug 2010, 11:49 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
A New 180-Day Exclusivity Punt - But Don't Read Too Much Into It
7 Jun 2010, 7:21 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA’s PLAIR Program Collides With Hatch-Waxman
23 May 2012, 7:37 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
NJ District Court Dismisses Patent Use Code Counterclaim as Not Valid Under Current Law; All Eyes Move to the Supreme Court PRANDIN Use Code Case
21 Nov 2011, 5:35 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
DC District Court Rules for FDA in Generic SEROQUEL Exclusivity Case; Grants Motion for Summary Judgment
9 Jul 2012, 7:41 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/