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Congressional Interest in FDA Remains High, Even After the Enactment of FDASIA
20 Aug 2012, 6:59 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Congressional Interest in FDA Remains High, Even After the Enactment of FDASIA
20 Aug 2012, 6:59 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Push for 12-Year Biologics Exclusivity in TPP Agreement Continues as the Next Round of Negotiations Approaches
16 Aug 2012, 2:21 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA is Sued Again Over Pre-MMA 180-Day Exclusivity; This Time the Drug is Generic ACTOS
15 Aug 2012, 11:02 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Running Into a Glass Door (or Window); a Problem With the New “Window ANDA” Forfeiture Provision
12 Aug 2012, 11:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Rescinds Orphan Drug Exclusivity for Wilate; A First-of-its-Kind Decision
8 Aug 2012, 8:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Federal Circuit Rules That Hatch-Waxman “Safe Harbor” is Quite Broad in Dispute Over Enoxaparin Method Patent
7 Aug 2012, 7:43 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“Big RLD” Versus “Little rld” – What’s the Difference?
6 Aug 2012, 8:33 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Supreme Court Asked to Take Up Post-Mensing Bartlett Generic Drug Labeling Preemption Decision
2 Aug 2012, 10:17 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
PDUFA V Begins With Relatively Modest Changes to User Fee Rates
31 Jul 2012, 10:22 am 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/
New Director Tapped to Head FDA’s Office of Generic Drugs
13 Jul 2012, 4:03 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/
FDA Sued for Abrogating MAKENA Orphan Drug Exclusivity; Suit Alleges that FDA is Turning a Blind Eye to Compounded 17P and Bowing to Political Pressure
8 Jul 2012, 7:01 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Announces Intent to Take Enforcement Action With Respect to Certain Marketed Unapproved Oxycodone Drug Products; Denies Lannett “Grandfather” Drug Petition
5 Jul 2012, 9:03 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Presidential Commission Seeks Comment on the Development of Medical Countermeasures for Children
28 Jun 2012, 8:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Petitioned on 180-Day Exclusivity Forfeiture for Tentative Approvals that Occur on the 30-Month ANDA Submission Anniversary Date
27 Jun 2012, 5:38 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/
FDA Once Again Departs From Conventional Bioequivalence Metrics and Sets Partial AUC Parameters for Generic ADDERALL XR
24 Jun 2012, 11:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
A 505(b)(2) NDA in Search of a Basis for Submission and Approval; the Curious Case of Morphine Sulfate Oral Solution
21 Jun 2012, 6:52 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/