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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/
GAO Says FDA Needs to do More to Address “Economic Adulteration”
27 Nov 2011, 12:08 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Legal Setbacks and Legislative Inaction May Push the FTC to Consider “Plan C” to Address Patent Settlement Agreements
29 Nov 2010, 1:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Completes Implementation of Affordable Care Act Sec. 10609 “Generic Loophole” Provisions
12 May 2011, 7:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Nevada State Court Judge Says There’s a Hole in Mensing Preemption for Some “Dear Doctor” Letters
5 Sep 2011, 2:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
It Ain’t Over ‘Til It’s Over – The ANGIOMAX PTE Battle Takes Yet Another New Turn
26 Sep 2011, 12:30 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
D.C. Circuit is Asked to Review Two DESI “New Drug” Decisions
2 May 2011, 5:45 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Denies Citizen Petition on Generic COMBIVIR 180-Day Exclusivity “First Applicant” Issue
1 Jun 2011, 5:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
APP Moves Forward With Appeal Notice in ANGIOMAX PTE Litigation in Light of PTO/FDA Indecision
2 Sep 2010, 10:21 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FTC Issues FY 2011 Patent Settlement Report; Attempts to Keep Up the Heat on Passage of the Preserve Access to Affordable Generics Act
25 Oct 2011, 2:44 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/
STOPP Act Would Establish New Requirements for Tamper-Resistant Drugs
24 Jul 2012, 7:58 pm 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/
Revelations: FDA’s Perspective on Drugs Marketed Pursuant to a Pending DESI Proceeding and the Unapproved Drugs CPG
14 Dec 2011, 6:03 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Obesity Epidemic: FDA’s Growing Waistline!
3 Sep 2012, 2:51 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/
The Preserve Access to Affordable Generics Act Resurfaces Early in the 112th Congress
30 Jan 2011, 11:20 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Snowmageddon, a Government Shutdown, and Other Acts of Nature (Mother or Human) – What are the Effects on FDA Approval Decision Deadlines?
1 Mar 2011, 1:32 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
You Had Us At “Biosimilars,” FDA; Agency Ties Up Yet Another Biosimilars Loose End With Petition Response Concerning Certain “Biological Drugs”
21 Mar 2012, 5:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Orange Book Patent Listing Precipitates DJ Action to Trigger Generic KEPPRA XR 180-Day Exclusivity Forfeiture
28 Mar 2011, 2:42 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/