Search for: "Kurt R. Karst" Results 221 - 240 of 363
Sorted by Relevance | Sort by Date
RSS Subscribe: 20 results | 100 results
FDA Takes Another Hit in Court in Animal Feed Antibiotics Litigation; Court Says Agency’s Petition Denials Are Arbitrary and Capricious
6 Jun 2012, 8:52 pm 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/
New Jersey District Court Denies Preliminary Injunction Motion in Generic CARBATROL Pre-MMA 180-Day Exclusivity Case; An Appeal Quickly Follows
7 Jul 2011, 3:38 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/
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/
Court Dismisses, on Ripeness Grounds, Cephalon Challenge to Generic FENTORA Approval
18 Jul 2011, 5:16 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/
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/
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/
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/
FDA Approval of Generic IMITREX STATdose Sheds Some Light on Auto-Injector “Sameness” Issues – But What About Other Combination Products?
8 Aug 2011, 5:18 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Senator Cites Ethical “Defect” in Biosimilars Law Exclusivity Provisions; Proposes Legislative Fix
4 Nov 2010, 10:09 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Wraps Up Responses to 2003 & 2004 Petitions on “Biosimilars”; Denies Outstanding Requests
16 Feb 2012, 5:56 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/
U.S. Supreme Court Petitioned to Review Federal Circuit Patent Use Code Decision
28 Dec 2010, 10:58 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Here It Goes, Here It Goes, Here It Goes Again: The Build Back Better Act (Redux)
13 Jul 2022, 10:39 pm by Kurt R. Karst
Koblitz & Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
California Court of Appeal Affirms Superior Court Decision that CIPRO Patent Settlement Agreements Do Not Violate State Antitrust Laws
1 Nov 2011, 6:12 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/
Decision in Lannett THALOMID Bioequivalence Study Sample Antitrust Lawsuit Could Reignite Debate on Generic Drug Availability and REMS Restrictions
3 Apr 2011, 10:21 pm 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/