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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/
Analyst Report Suggests Recent Uptick in NDA/BLA Refuse-to-File Letters Signals Changes at FDA
26 Apr 2011, 1:56 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FTC Annual Report Highlights the Commission’s Patent Settlement Efforts
25 Apr 2010, 5:52 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Cements “It’s Our Party and We’ll Punt if We Want to” Stance on 180-Day Exclusivity Failure to Obtain Tentative Approval Forfeiture Decisions
11 Mar 2012, 4:43 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Reports Detail FDA’s 505(q) Citizen Petition Response Track Record; Section 505(q) May Have Some Unintended Consequences, FDA Says (Part II)
25 Jan 2011, 6:31 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
REMS and 180-Day Exclusivity Forfeiture – Some Interesting Disclosures to the SEC
28 Oct 2010, 10:14 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Sandoz Attempts to Clear Up Post-Losartan “Bottleneck” with DJ Action on Disclaimed Patent
22 Nov 2010, 1:24 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Running Into a Glass Door (or Window); a Problem With the New “Window ANDA” Forfeiture Provision
12 Aug 2012, 11:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Rep. Schakowsky Introduces Safe Cosmetics Act of 2010; Bill Would Increase Regulation of Cosmetics
21 Jul 2010, 11:08 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Patent Expiration, Pediatric Exclusivity, and Generic Drug Approval – Some Interesting Tensions Between the FDC Act and Patent Law
18 Aug 2010, 11:34 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Hot Ticket Item – Patent Settlement Agreement Challenges
29 Aug 2012, 10:09 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Lawsuit Seeks to Compel FDA Compliance with PDUFA User Fee Waiver Provisions
13 Oct 2011, 3:17 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
HP&M Attorneys Receive Accolades: Top Lawyer Under 40 and WWL: Life Sciences 2023 Global Elite Thought Leader
27 Jun 2023, 2:29 am by Hyman Phelps McNamara
Karst Awarded WWL: Life Sciences 2023 Global Elite Thought Leader HP&M Director Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA Announces New "First Generics" Policy for Review of ANDAs
20 Oct 2006, 4:11 pm
Galson's presentation at the GPhA Fall Technical Conference CDER's "Review Order of Original ANDAs, Amendments, and Supplements" policy document NOTE:  thanks to Kurt Karst for passing along this news. [read post]
Orange Book Blog - http://www.orangebookblog.com/
ICD2 2012 Conference - Fostering Innovation and Translational Research in Support of Public Health and Economic Growth
28 Nov 2011, 7:26 pm by FDABlog HPM
’s Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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/
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