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The Obesity Epidemic: FDA’s Growing Waistline!
3 Sep 2012, 2:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Hot Ticket Item – Patent Settlement Agreement Challenges
29 Aug 2012, 10:09 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Gears Up for GDUFA Implementation and ANDAgeddon
23 Aug 2012, 6:01 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/
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/
Conte Rejected Again
10 Aug 2012, 7:48 am by Bexis
Thanks to Kurt Karst at Hyman Phelps for passing along Strayhorn. [read post]
Drug and Device Law - http://druganddevicelaw.blogspot.com/
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/