Search for: "Kurt Karst" Results 241 - 260 of 371
Sorted by Relevance | Sort by Date
RSS Subscribe: 20 results | 100 results
District Court’s Extension of 30-Month Stay on Generic XYZAL Approval Ends; ANDA Sponsors are Itching for an FDA Decision on “Carved-Out” Urticaria-Only Labeling
23 Feb 2011, 10:58 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/
Pallone Bill Takes an “Oscar Rogers Approach” to 180-Day Exclusivity Forfeiture and FDA’s Office of Generic Drugs: FIXIT!
1 Apr 2012, 8:58 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/
First Dust Up Over Generic PROVIGIL 180-Day Exclusivity Quickly Put on Hold With TRO/PI Motion Withdrawal, But is Followed Up With a Second Lawsuit
5 Apr 2012, 1:41 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/
“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/
FDA Once Again Departs From Conventional Bioequivalence Metrics and Sets Partial AUC Parameters for Generic ADDERALL XR
24 Jun 2012, 11:40 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/
Last-Ditch Effort to Jettison “The Dog Ate My Homework Act” from the America Invents Act Fails
8 Sep 2011, 8:10 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/
Generic LIPITOR - the Brass Ring of All Brass Rings for 180-Day Exclusivity; How Will Exclusivity Resolve?
12 Oct 2010, 1:28 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/
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/
New Reports on FDA Drug Approval Performance Emerge as House Committee Considers User Fee Reauthorization Legislation
10 May 2012, 11:14 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Strength in Numbers? The Lobbying Push for a PTE
21 Aug 2011, 6:49 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Citizen Petition Requests Rulemaking Process for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions
6 Sep 2011, 4:00 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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/
McNeil Petitions the U.S. Supreme Court on OTC Drug Labeling Failure-to-Warn Preemption Issue
7 Dec 2010, 12:19 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/