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Will the Dog Days of Summer Offer a Reprieve to FDA and the Regulated Industry (and Your Bleary-Eyed Bloggers)? Doubtful
6 Jul 2011, 10:52 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
PDUFA IV User Fees End With a Bang, Not a Whimper! Application Fee Increases by a Whopping 19.4% (or Almost $300K)
31 Jul 2011, 5:03 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
WSJ Stakes Out Position on Patent Settlements; Takes Issue with the FTC’s “Evangelical Zeal”
5 Oct 2010, 10:53 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
USTR Embraces “TEAM” Approach in TPP Talks; Senators Back 12-Year Exclusivity for Biologics
13 Sep 2011, 5:32 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
PDUFA V Begins With Relatively Modest Changes to User Fee Rates
31 Jul 2012, 10:22 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Another Push to Legislatively Overturn Forest Group False Marking Decision
11 Oct 2010, 12:59 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Sen. Casey Takes Over the Reins for the Creating Hope Act; New Bill Substantially Mirrors Sen. Brownback’s 2010 Version
21 Mar 2011, 1:12 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Full Circle: Rush Bill Would Make Most Patent Settlement Agreements Unlawful
13 Feb 2012, 8:07 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Ramps Up Enforcement on Marketed Unapproved Human Drugs – Revised CPG Says New Products Will be Subject to Immediate Enforcement Action
19 Sep 2011, 11:03 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Says There is No Scientific Evidence of Problems in Switching Bioequivalent Anti-epileptic Meds, But Further Study is Warranted
21 Nov 2010, 5:58 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
District Court Vacates 30-Month Stay Extension; Says Stay Only Applies to ANDAs Containing a Paragraph IV Certification
27 Sep 2011, 4:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Another Capitol Hill Missive Objects to the Inclusion of Patent Settlement Provisions in FY 2011 Appropriations Bill
27 Oct 2010, 7:12 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Leahy Bill Would Legislatively Undo the U.S. Supreme Court’s Mensing Decision
29 Mar 2012, 6:23 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
NORD Petition Requests FDA Policy Statement on Orphan Drug Review Flexibility
8 Sep 2011, 7:12 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
House Passes Bill to Repeal Medical Device Excise Tax; Veto Threat Looms
7 Jun 2012, 6:39 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Tussle over BPCIA “Market” Versus “Data” Exclusivity Continues; This Time the Generic Supporters Chime In
21 Jan 2011, 6:38 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Seeks to Clean Up Unapproved Cough/Cold/Allergy Drug Market
6 Jan 2011, 1:35 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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/
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/
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/