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President Obama to Nominate Maureen K. Ohlhausen to the Federal Trade Commission
20 Jul 2011, 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/
The MDCO PTE Decision: In Play on Capitol Hill and in Action at the PTO
14 Jul 2011, 12:19 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Priority Review Vouchers – Not Much Bang for the Buck
11 Jul 2011, 4:47 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New Jersey District Court Denies Preliminary Injunction Motion in Generic CARBATROL Pre-MMA 180-Day Exclusivity Case; An Appeal Quickly Follows
7 Jul 2011, 3:38 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Will the Dog Days of Summer Offer a Reprieve to FDA and the Regulated Industry (and Your Bleary-Eyed Bloggers)? Doubtful
6 Jul 2011, 10:52 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Lobbying for a Patent Term Extension
5 Jul 2011, 11:07 pm by Dennis Crouch
Notes: Kurt Karst has been following the case in detail at his FDA Law Blog. [read post]
Patently-O - http://www.patentlyo.com/patent/
FDA is Sued Over Product Designation Determination; Lawsuit Seeks Device Declaration and to Vacate FDA’s Drug Findings
30 Jun 2011, 1:45 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Is Information Contained in a Paragraph IV Certification Notice Letter Accompanied by an Offer of Confidential Access Subject to Public Disclosure? One District Court has an Answer
29 Jun 2011, 8:15 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Efforts to Obtain a PTE for ANGIOMAX Patent Continue as the U.S. House Passes an Amendment to the America Invents Act in “After Business Hours” Vote
28 Jun 2011, 2:03 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Supreme Court Issues Decision on Generic Drug Preemption; To Borrow From Harry Caray – “Holy Cow! Generics Win! Generics Win!”
23 Jun 2011, 9:23 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New IP resource for Pharma, Biotech and Chem Finding the right model for Research & Development Collaboration
20 Jun 2011, 10:15 pm by Duncan
Jenkins, UK Fabrizio Jacobacci, Studio Legale Jacobacci & Associati, Italy Kurt R. [read post]
IP Thinktank - http://duncanbucknell.com/ipthinktank.blog
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/
Smarter than the Average Bear? Two Recent Lifecycle Management Strategies of Note
13 Jun 2011, 5:32 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Issues Final 505(q) Citizen Petition Guidance, Says Certification/Verification Statement Accuracy is Paramount
9 Jun 2011, 12:54 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDLI Conference – Brands, Generics and Hatch-Waxman: New Challenges; Unabated Controversy
7 Jun 2011, 10:15 am by FDABlog HPM
’s Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
GAO Report Finds BPCA and PREA to be Ongoing Successes, But Says that FDA Needs to Improve Tracking of Products Studied for Pediatric Uses
6 Jun 2011, 5:21 pm by FDABlog HPM
Shah & Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Denies Citizen Petition on Generic COMBIVIR 180-Day Exclusivity “First Applicant” Issue
1 Jun 2011, 5:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA is Sued Over Generic CARBATROL; Lawsuit Challenges FDA Decisions on Pre-MMA 180-Day Exclusivity
30 May 2011, 6:34 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Nonprofit Groups Sue FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal Feed, Seek Approval Withdrawals and Citizen Petition Response
26 May 2011, 1:49 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/