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10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements is Just Days Away
23 Jun 2022, 6:56 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA in the Multiverse of 180-Day Exclusivity Madness: Is an “Incursion” in the Cards for our “Exclusivity Earth-616”?
26 May 2022, 10:30 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
A New Report Takes an Evidence-Based Approach to Analyzing the BLOCKING Act
25 May 2022, 12:00 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA, in a RARE Act, Takes To Lobbying for a Change to the Orphan Drug Act
17 May 2022, 7:18 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
ACI’s 17th Annual Paragraph IV Disputes Conference (In-Person and Livestream)
14 Apr 2022, 10:49 am by Hyman Phelps McNamara
’s Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
ACI 36th Annual FDA Boot Camp
27 Feb 2021, 8:02 pm by Patent Docs
ACI faculty will give presentations on: • Understanding the Relevance of New FDA Initiatives and Policies and How They May Redefine the Life Sciences Industry in the Aftermath of COVID-19, by co-chairs Kurt K. [read post]
Patent Docs - http://www.patentdocs.org/
Webinar on Biologics and Biosimilars
12 Jan 2019, 8:07 pm by Patent Docs
Feldstein of Finnegan Henderson Farabow Garrett & Dunner and Kurt R. [read post]
Patent Docs - http://www.patentdocs.org/
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/
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/
Blog Updates: ABA Blawg 100
1 Dec 2015, 6:06 am by Dennis Crouch
Patent Related Blawgs this year include Ross Dannenberg’s Patent Arcade, Courtenay Brinkerhoff’s PharmaPatents, Scott McKeown’s Patent Post Grant, and Kurt Karst’s FDA Law Blog. [read post]
Patently-O - http://patentlyo.com/patent
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
ACI "Legal and Regulatory Summit on Generic Drugs," New York City, July 17-18
1 Jul 2013, 8:35 pm by Aaron Barkoff
 The conference co-chairs are Shashank Upadhye, formerly of Apotex, and Kurt Karst of FDA Law Blog. [read post]
Orange Book Blog - http://www.orangebookblog.com/
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/
“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/
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/
Our GDUFA Cup Runneth Over! FDA Sets Several FY 2013 User Fee Rates
25 Oct 2012, 12:26 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Revised Formula Yields a Lower Priority Review Voucher User Fee of $3,559,000; Will That Help Spark Greater Interest in the Program?
12 Sep 2012, 6:46 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Brand-Name Side of the Exclusivity Equation; Exclusivity Under Fire
10 Sep 2012, 7:28 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17P
6 Sep 2012, 5:25 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/