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A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House
24 Jan 2024, 9:11 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA Files Amicus Brief on Generic Drug Preemption
16 Nov 2010, 5:16 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Psych! Second Circuit Denies Rehearing Petition in CIPRO Patent Settlement Litigation after Panel Invites Petition
9 Sep 2010, 12:20 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
A New Hope? Second Circuit Invites Further Review in CIPRO Patent Settlement Case
4 May 2010, 11:40 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Nonprofit Groups Sue FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal Feed, Seek Approval Withdrawals and Citizen Petition Response
26 May 2011, 1:49 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Former DEA Administrators Weigh in on Marijuana Rescheduling
1 Jul 2024, 2:54 pm 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/
“Size Matters,” Says FDA, When it Comes to Generic Drug-RLD Sameness
4 Jan 2012, 5:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
NJ District Court Declines to Exercise Declaratory Judgment Jurisdiction in Feud Over Generic ANTARA; Lupin is Given Another Bite at the Apple
20 Jan 2011, 1:03 pm by Hyman, Phelps & McNamara, P.C.
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Sessions/Coburn Amendment to FDA Approps Bill Seeks To Effectively Nullify AIA Section 37 ANGIOMAX PTE Provision
20 Oct 2011, 7:55 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Congressional Interest in FDA Remains High, Even After the Enactment of FDASIA
20 Aug 2012, 6:59 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Déjà vu! Senators Follow House Colleagues in Making BPCIA Exclusivity Clarifications; New Study Suggests Benefits of Longer Drug Exclusivity Period
11 Jan 2011, 11:38 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Congressional Interest in FDA Remains High, Even After the Enactment of FDASIA
20 Aug 2012, 6:59 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
GAO Report Says That FDA Has Met Most PDUFA Performance Goals; Agency Plans to Take Steps to Address Lingering Stakeholder Concerns
2 May 2012, 7:22 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Federal Circuit Denies Rehearing Petition in PRANDIN Patent Use Code Case; Dissents Argue that “Section viii” Carve-Outs Eviscerated
29 Jul 2010, 10:24 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“Preserve Access to Affordable Generics Act” Resurfaces in Senate; Patent Settlement Litigation Front Heats Up
10 Jun 2010, 10:41 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Lawsuit Alleges False Marking Based on Orange Book “Advertising”
13 Apr 2011, 5:13 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FTC Commissioner Objects to Certain Provisions in Senate FDA User Fee Reauthorization Legislation
5 Jun 2012, 7:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Push for 12-Year Biologics Exclusivity in TPP Agreement Continues as the Next Round of Negotiations Approaches
16 Aug 2012, 2:21 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Senate and House Bills Seek to Legislatively Overturn the Supreme Court’s Mensing Decision
19 Apr 2012, 7:08 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/