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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/
A Flurry of Amicus Briefs Filed in the K-DUR Patent Settlement Appeal Seek a Reversal of a New Jersey District Court Decision
23 May 2011, 1:54 pm 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 – Confidential information protection and jurisdictional differences
18 May 2011, 9:45 pm by Duncan
Jenkins, UK Fabrizio Jacobacci, Studio Legale Jacobacci & Associati, Italy Kurt R. [read post]
IP Thinktank - http://duncanbucknell.com/ipthinktank.blog
ISTA Sues FDA Over Generic XIBROM Approval, Says ANDA Approval Should Disappear in the Blink of An Eye
17 May 2011, 5:51 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FTC Alleges Companies Were Asleep At the Wheel When They Failed to Report Settlement Agreements on AMBIEN CR; Commission Uses the Opportunity to Provide Industry Guidance – And a Warning
15 May 2011, 2:54 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/
D.C. District Court Grants FDA Motion for Summary Judgment in Spat Over Generic ALDARA Cream
10 May 2011, 10:40 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Gets the Ball Rolling on Biosimilar/Interchangeable Biological Product User Fee Program; Proposal Gives a Hat Tip to PDUFA While Acknowledging the Nascent State of the Industry
9 May 2011, 5:05 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/