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FDA Proposes to Depart From Conventional Bioequivalence Metrics; Draft Guidance Proposes Partial AUC for Generic RITALIN LA
30 Nov 2011, 5:07 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Priority Review Vouchers – Not Much Bang for the Buck
11 Jul 2011, 4:47 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/
The Other Shoe Drops: ViroPharma Sues FDA – Challenges Denial of 3-Year Exclusivity and ANDA Approvals
16 Apr 2012, 1:29 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Tobacco Companies Sue FDA Over Graphic Warnings Rule
17 Aug 2011, 3:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Supreme Court Rules in Patent Use Code Case; Reverses Federal Circuit Decision
17 Apr 2012, 5:55 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Ninth Circuit Joins the Fifth and Eighth Circuits with Generic Drug Labeling Preemption Decision
24 Jan 2011, 3:15 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/
New Jersey District Court Says ANDA Approval Delay and Patent Uncertainty Are Insufficient to Support DJ Jurisdiction in Generic DETROL LA Litigation
10 Nov 2011, 7:16 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Improving Access to Clinical Trials Act Becomes Law
19 Oct 2010, 10:12 am 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 Reports to Congress on Generic Anti-Epileptic Drugs; Concludes that Additional Study of Brand-Generic Switching is Needed to Better Understand Risks
13 Apr 2011, 10:10 am 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/
The FTC’s Latest Patent Settlement Report Will Serve as Fodder for the Commission’s Crusade Against Patent Settlement Agreements
8 May 2011, 8:13 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
D.C. District Court Grants FDA Motion for Summary Judgment in Spat Over Generic ALDARA Cream
10 May 2011, 10:40 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Fifth Circuit Vacates District Court “Second Inspection Ruling” in Compounding Pharmacy Case
28 Feb 2011, 3:53 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/
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/
FDA Announces Major Enforcement Action on Marketed Unapproved Prescription Cough, Cold, and Allergy Drug Products
2 Mar 2011, 10:27 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
It Lives!! Apotex Asks the Supreme Court to Review Generic COZAAR/HYZAAR 180-Day Exclusivity Decision (Our 1,000th Post)
5 Oct 2010, 2:58 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/