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Graceway Sues FDA Over Generic ALDARA Cream Decisions; Alleges that Petition Response is Contrary to Basic Science, Common Sense, and Precedent
13 Jul 2010, 12:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Court Orders and PTO Grants Second Interim PTE for ANGIOMAX
24 May 2010, 12:54 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New Analysis Takes Issue with CBO Patent Settlement Legislation Cost Estimate
16 Aug 2010, 8:10 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
In Litigation Over Animal Feed Antibiotic Withdrawals, District Court Says FDA Needs to Move Forward
22 Aug 2012, 3:02 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Relinquishment and Waiver of 180-Day Exclusivity Post-MMA; What is FDA Precedent and Where Might FDA be Headed?
14 Jun 2010, 1:07 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Issues NOOH Proposing to Withdraw All Midodrine HCl Approvals
16 Aug 2010, 1:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Federal Circuit Denies Rehearing Petition in LEVAQUIN Patent Term Extension Case
19 Jul 2010, 1:12 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
You Better Watch Out, and You Can Pout, but FDA User Fee Invoices Are Coming Out; FDA is Making a List and Checking it Twice – You Should Too!
18 May 2010, 8:35 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Cody/Lannett Unapproved Morphine Sulfate Litigation Gets New Legs; But FDA Motion to Dismiss Tries to Pull the Rug Out From Under Them
6 Sep 2010, 4:38 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“If You’ve Got Legitimate Suspenders, Don’t Have an Unconstitutional Belt:” Federalist Society Panel’s Take on Jarkesy and the Preserve Access to Affordable Generics and Biosimilars Act
3 Dec 2024, 8:41 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Federal Circuit Sides with FDA and PTO in CYDECTIN PTE Decision; Court Rules that Approval Phase Begins when Administrative NADA is Initially Submitted
3 May 2010, 11:11 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA in the Multiverse of 180-Day Exclusivity Madness: Is an “Incursion” in the Cards for our “Exclusivity Earth-616”?
26 May 2022, 10:30 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Sandoz Requests 180-Day Exclusivity Forfeiture Decision for Generic HECTOROL
21 Dec 2010, 11:00 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government
1 Oct 2024, 8:21 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
The Showdown Over AIA Section 37 Looms . . . .
14 Nov 2011, 4:46 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Our GDUFA Cup Runneth Over! FDA Sets Several FY 2013 User Fee Rates
25 Oct 2012, 12:26 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
A New Hatch-Waxman DJ Jurisdiction Decision . . . . And an Added Twist
24 Jan 2012, 6:34 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
District Court’s Extension of 30-Month Stay on Generic XYZAL Approval Ends; ANDA Sponsors are Itching for an FDA Decision on “Carved-Out” Urticaria-Only Labeling
23 Feb 2011, 10:58 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
McNeil Petitions the U.S. Supreme Court on OTC Drug Labeling Failure-to-Warn Preemption Issue
7 Dec 2010, 12:19 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Drug Purchasers Petition U.S. Supreme Court to Consider CIPRO Patent Settlement Case
8 Dec 2010, 10:42 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/