Search for: "Kurt R. Karst" Results 221 - 240 of 363
Sorted by Relevance | Sort by Date
RSS Subscribe: 20 results | 100 results
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/
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/
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/
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/
Simultaneously Qualifying for and Forfeiting 180-Day Exclusivity Eligibility for Failure to Obtain Timely Tentative Approval
12 Apr 2011, 2:47 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
PTO Sued After Denying “Mildly Tardy” Second Interim PTE Request
12 Jan 2011, 10:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Says Tenth Circuit Should Say Adieu to Grandfather Drug Case Without Much Ado; Not So Fast, Says Cody/Lannett
15 Aug 2011, 6:20 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 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/
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/
DC District Court Grants FDA Summary Judgment in Generic LOVENOX Dispute
7 Feb 2012, 2:25 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/
“Soon” Has Finally Come; FDA Issues Three Highly Anticipated Biosimilars Draft Guidances
10 Feb 2012, 1:09 am by FDABlog HPM
By 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/
GAO Report Criticizes FDA on Antibiotic Labeling; Finds No Evidence of Encouraged Innovation
1 Feb 2012, 1:22 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Supreme Court Asked to Take Up Post-Mensing Bartlett Generic Drug Labeling Preemption Decision
2 Aug 2012, 10:17 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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/
VIAGRA Patent Decision Gives Rise to Dispute Over ANDA Approval, Concern About 180-Day Exclusivity Forfeiture; Court Rigidly Applies Patent Statute
24 Oct 2011, 1:39 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Sued for Abrogating MAKENA Orphan Drug Exclusivity; Suit Alleges that FDA is Turning a Blind Eye to Compounded 17P and Bowing to Political Pressure
8 Jul 2012, 7:01 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Coming 505(q) Citizen Petition Cliff and Some Interesting Petition Strategies
4 Sep 2012, 6:38 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/