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A Federal Court Win on the RLD Theory of Liability; More of Moore Will Likely be Called For
9 Jan 2012, 6:24 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“Size Matters,” Says FDA, When it Comes to Generic Drug-RLD Sameness
4 Jan 2012, 5:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
ULTRA Bill Introduced in the House; Legislation Seeks to Permit Broader Use of Scientific Data to Support Surrogate Endpoints for “Ultra Orphan” Drug Approvals
2 Jan 2012, 6:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New Stuff #3
15 Dec 2011, 12:28 pm by Bexis
  Id. at *6.Thanks to Kurt Karst at the FDA Law Blog for passing this decision along. [read post]
Drug and Device Law - http://druganddevicelaw.blogspot.com/
Revelations: FDA’s Perspective on Drugs Marketed Pursuant to a Pending DESI Proceeding and the Unapproved Drugs CPG
14 Dec 2011, 6:03 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Pending DESI Program Proceedings – The List
11 Dec 2011, 4:44 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Latest Generic Preemption Decision
9 Dec 2011, 12:18 pm by Bexis
Nov. 7, 2011).Thanks to Kurt Karst at the FDA law blog for the tip. [read post]
Drug and Device Law - http://druganddevicelaw.blogspot.com/
FDA Proposes Generic Drug User Fee System and Performance Goals
7 Dec 2011, 7:25 am 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FDA Proposes to Depart From Conventional Bioequivalence Metrics; Draft Guidance Proposes Partial AUC for Generic RITALIN LA
30 Nov 2011, 5:07 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
ICD2 2012 Conference - Fostering Innovation and Translational Research in Support of Public Health and Economic Growth
28 Nov 2011, 7:26 pm by FDABlog HPM
’s Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
GAO Says FDA Needs to do More to Address “Economic Adulteration”
27 Nov 2011, 12:08 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Withdraws Avastin Breast Cancer Indication Approval
22 Nov 2011, 7:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
NJ District Court Dismisses Patent Use Code Counterclaim as Not Valid Under Current Law; All Eyes Move to the Supreme Court PRANDIN Use Code Case
21 Nov 2011, 5:35 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The FAIR Generics Act Makes its Debut; the Bill Takes a New Tack in Addressing Patent Settlement Agreements
16 Nov 2011, 5:41 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA is Sued After Approving Generic Topical Corticosteroid Drug Products; Lawsuit Seeks Withdrawal or Suspension of ANDA Approvals
16 Nov 2011, 5:18 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Patent Settlement Agreements Remain in the Spotlight, But Not the Unified Spotlight the FTC Might Want
15 Nov 2011, 2:10 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Showdown Over AIA Section 37 Looms . . . .
14 Nov 2011, 4:46 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 Says ANDA Approval Delay and Patent Uncertainty Are Insufficient to Support DJ Jurisdiction in Generic DETROL LA Litigation
10 Nov 2011, 7:16 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Will the Hatch-Waxman Lock be Sprung in 2012?
7 Nov 2011, 1:07 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/