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Public Citizen Petitions FDA to Amend Generic Drug Labeling Regulations in the Wake of Mensing
29 Aug 2011, 12:30 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Completes Implementation of Affordable Care Act Sec. 10609 “Generic Loophole” Provisions
12 May 2011, 7:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
32 State AGs Urge U.S. Supreme Court to Take on Patent Settlement Agreements
10 Jan 2011, 5:54 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Nevada State Court Judge Says There’s a Hole in Mensing Preemption for Some “Dear Doctor” Letters
5 Sep 2011, 2:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Landmark NORD Report on Orphan Drugs Authored By HP&M Director Shows FDA Flexibility in Approval
11 Oct 2011, 1:53 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Orange Book Patent Listing Precipitates DJ Action to Trigger Generic KEPPRA XR 180-Day Exclusivity Forfeiture
28 Mar 2011, 2:42 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Pending DESI Program Proceedings – The List
11 Dec 2011, 4:44 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Denies ECR & Laser GRASE Petitions Following Voluntary Dismissal of Related Lawsuits
10 Aug 2011, 3:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Fat Lady Goes Back to Her Dressing Room; Federal Circuit Denies MDCO Motions in ANGIOMAX PTE Litigation
6 Feb 2011, 10:41 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
You Had Us At “Biosimilars,” FDA; Agency Ties Up Yet Another Biosimilars Loose End With Petition Response Concerning Certain “Biological Drugs”
21 Mar 2012, 5:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Apotex Cert Petition on 180-Day Exclusivity Forfeiture Decision is DOA, Says Teva in Opposition Brief
13 Dec 2010, 4:55 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
OGD Finished 2010 on a High Note – Really High!
3 Feb 2011, 2:01 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FTC Issues FY 2011 Patent Settlement Report; Attempts to Keep Up the Heat on Passage of the Preserve Access to Affordable Generics Act
25 Oct 2011, 2:44 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Coda in the ANGIOMAX Symphony; Approaching Fine (the End)
9 Feb 2012, 4:06 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
In a Rare Move, District Court Extends 30-Month Stay on FDA ANADA Approval
20 Jun 2011, 7:01 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Solicitor General Files Amicus Brief in Mensing Cases on Generic Drug Preemption; Recommends that the Supreme Court Deny Review
2 Nov 2010, 11:11 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
District Court Grants FDA Motion to Dismiss in Unapproved Morphine Sulfate Litigation
17 Nov 2010, 6:33 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
STOPP Act Would Establish New Requirements for Tamper-Resistant Drugs
24 Jul 2012, 7:58 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Amendment to the America Invents Act Would Give MDCO Some Legislative Security in Battle Over ANGIOMAX PTE
20 Apr 2011, 5:21 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
It Ain’t Over ‘Til It’s Over – The ANGIOMAX PTE Battle Takes Yet Another New Turn
26 Sep 2011, 12:30 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/