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FDA Issues Proposed PDUFA V Performance Goals & Procedures
7 Sep 2011, 8:37 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“Bring Out Your Dead” Says OGD in a Pre-GDUFA House Cleaning Move as the Agency Prepares for ANDAgeddon
13 Jun 2012, 10:31 am 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/
FDA Denies Petition Seeking to Add Application Information to Drug Labels
12 Jan 2012, 4:33 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
When Can’t a “Listed Drug” Serve as a Reference Product for a 505(b)(2) Application?
19 Jun 2012, 7:44 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Apotex Seeks to Trigger 180-Day Exclusivity for Generic LEXAPRO Tablets
17 Jan 2011, 9:27 am 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/
Making the House FDA Reform Act of 2012 PAYGO Compliant – Are Expedited 505(q) Citizen Petition Responses the Answer?
28 May 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 Prevails in 10th Circuit Unapproved Morphine Sulfate Case; Court Does Not Reach Merits of Grandfather Claim
6 Nov 2011, 10:57 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Orange Book Patent Delisting Counterclaim Raised in 505(b)(2) Application Patent Infringement Litigation; Decision Could Provide Guidance on Drug Delivery System Patent Listability
8 Mar 2011, 12:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“RLD Theory of Liability” Continues to Fall Flat; Multiple Court Decisions Build Momentum in Generic Drug Failure-to-Warn Preemption Litigation
19 Mar 2012, 1:31 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Updated House Energy & Commerce UFA Bill Would Shorten FDA’s 505(q) Petition Response Timeframe; Require Timely Responses to RLD Withdrawal Petitions
7 May 2012, 4:42 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Scope of New Chemical Entity Exclusivity and FDA’s “Umbrella” Exclusivity Policy
20 Jul 2011, 8:34 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Proposes Biosimilar and Interchangeable Biological Product User Fee System and Performance Goals
6 Dec 2011, 9:25 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/
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/
Will the Fourth Time be the Charm? FDA is Once Again Asked for Guidance on Drug Delivery Device Patent Orange Book Listing
21 Jul 2011, 4:50 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Pennsylvania District Court Issues an XL Decision in WELLBUTRIN XL Antitrust, Sham Citizen Petition Case
30 May 2012, 6:56 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The YASMIN Case: Is it Conceivable (or Not) that Hatch-Waxman Method Patent Infringement Lawsuits are Limited to Information in the “Indications and Usage” Drug Labeling Section?
22 Feb 2012, 5:49 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Revised Formula Yields a Lower Priority Review Voucher User Fee of $3,559,000; Will That Help Spark Greater Interest in the Program?
12 Sep 2012, 6:46 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/