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Blown 30-Month ANDA Tentative Approval and Approval Dates – A Growing Industry Concern; Is Litigation in the Works?
11 May 2010, 4:00 pm 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/
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/
On the Eve of PDUFA Reauthorization, DC District Court Strikes Down FDA Interpretation of PDUFA
25 Jun 2012, 8:53 pm 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/
“Preserve Access to Affordable Generics Act” Resurfaces in Senate; Patent Settlement Litigation Front Heats Up
10 Jun 2010, 10:41 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 LOVENOX Case; Is the Juice Worth the Squeeze for Sanofi to Appeal?
26 Aug 2010, 10:01 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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/
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/
District Court Decision Sidesteps 30-Month Stay Tolling Issue; Denies Patent Infringement Litigation Stay
19 Apr 2010, 1:34 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Novartis Sues FDA Over Generic FAMVIR; Alleges that FDA Failed to Require a Split Certification
23 Sep 2010, 12:39 pm 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/
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/
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/