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FDA Sued Over Enforcement Action on Marketed Unapproved Morphine Sulfate Oral Solution
22 Jul 2010, 1:11 pm 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/
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/
FDA Set to Announce Public Hearing on BPCI Act Implementation
20 Sep 2010, 7:28 am 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/
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/
District Court Denies Motion for Temporary Restraining Order and Preliminary Injunction in Marketed Unapproved Morphine Sulfate Oral Solution Case
26 Jul 2010, 9:04 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Losartan – D.C. Circuit Denies FDA’s Petition for Panel Rehearing and Rehearing en banc; Roxane/Apotex Case Continues
18 May 2010, 3:19 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Pennsylvania District Court Decision Signals a New Turn in the Generic Drug Preemption Debate; A Tough Pill to Swallow for the Generic Industry
2 Jun 2010, 12:42 pm 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/
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/
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/
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/
Generic LIPITOR - the Brass Ring of All Brass Rings for 180-Day Exclusivity; How Will Exclusivity Resolve?
12 Oct 2010, 1:28 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Court Dismisses, on Ripeness Grounds, Cephalon Challenge to Generic FENTORA Approval
18 Jul 2011, 5:16 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA is Sued After Approving Generic Topical Corticosteroid Drug Products; Lawsuit Seeks Withdrawal or Suspension of ANDA Approvals
16 Nov 2011, 5:18 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
AstraZeneca Loses TRO Bid in Second Generic SEROQUEL Lawsuit
29 Mar 2012, 5:47 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/