Search for: "Kurt R. Karst" Results 301 - 320 of 351
Sorted by Relevance | Sort by Date
RSS Subscribe: 20 results | 100 results
New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review
30 Apr 2023, 8:00 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
29 Feb 2012, 11:52 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Court Orders ANDA Approval in Pre-MMA 180-Day Exclusivity Case; Decision Appears to Have Post-MMA Implications
29 Oct 2012, 12:18 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Supreme Court Issues Decision on Generic Drug Preemption; To Borrow From Harry Caray – “Holy Cow! Generics Win! Generics Win!”
23 Jun 2011, 9:23 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees
27 Jun 2017, 9:00 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
BMJ Article on Clinical Trial Reporting Foments Discontent on Capitol Hill (Our 1,500th Post!)
15 Feb 2012, 4:20 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Another Advocacy Group Asks FDA to Increase Marketed Unapproved Drugs Enforcement Crackdown
12 Aug 2010, 12:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
ACI’s 12th Maximizing Pharmaceutical Patent Life Cycles Conference
3 Aug 2011, 10:41 am by FDABlog HPM
’s Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Issues New Guidance on PDUFA User Fee Waivers, Reductions, and Refunds; Guidance Represents the Culmination of 18 Years of FDA Experience
21 Mar 2011, 12:00 pm by FDABlog HPM
Butler & Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
OGD Has Put the Brakes on ANDA Supplement Reviews; Will it Help Push Generic Drug User Fees Along?
16 Sep 2010, 11:43 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“Product Hopping” Antitrust Lawsuit Takes on a Heightened Profile with Proposed FTC Amicus Brief
25 Nov 2012, 5:42 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act
10 Oct 2022, 6:51 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA Law: You’re Invited . . . To a Dance Party! Will You Dance the Amgen Waltz, or the Sandoz Shuffle?
28 Apr 2015, 9:14 am by Dennis Crouch
Guest Post By Kurt R. [read post]
Patently-O - http://patentlyo.com/patent
Leap Year and Hatch-Waxman – An Unusual Conundrum Years in the Making
23 Jan 2012, 4:37 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Coalition for Mercury-Free Drugs Fails to Prove Standing in Thimerosal Case
5 Jul 2010, 5:09 pm by FDABlog HPM
Varond* & Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II
28 Jun 2017, 7:31 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Apotex Seeks Exclusivity-Triggering Court Decision in Declaratory Judgment Action Over Generic BENICAR Patent
26 Nov 2012, 10:19 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The President’s FY 2012 Budget Would Create New User Fees, Ban Patent Settlements, and Reduce BPCIA Reference Product Exclusivity
15 Feb 2011, 10:05 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“Big RLD” Versus “Little rld” – What’s the Difference?
6 Aug 2012, 8:33 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Recent Hatch-Waxman Scholarship Suggests Patent Settlement and Product Hopping Create a “Lethal Combination”; Another Article Proposes a “Smith Barney Approach” to 180-Day Exclusivity
15 Mar 2011, 12:46 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/