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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/
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/
District Court Grants FDA Motion to Dismiss in Unapproved Morphine Sulfate Litigation
17 Nov 2010, 6:33 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Amendment to the America Invents Act Would Give MDCO Some Legislative Security in Battle Over ANGIOMAX PTE
20 Apr 2011, 5:21 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
32 State AGs Urge U.S. Supreme Court to Take on Patent Settlement Agreements
10 Jan 2011, 5:54 am 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/
The Fat Lady Goes Back to Her Dressing Room; Federal Circuit Denies MDCO Motions in ANGIOMAX PTE Litigation
6 Feb 2011, 10:41 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Proposes to Depart From Conventional Bioequivalence Metrics; Draft Guidance Proposes Partial AUC for Generic RITALIN LA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/
Solicitor General Files Amicus Brief in Mensing Cases on Generic Drug Preemption; Recommends that the Supreme Court Deny Review
2 Nov 2010, 11:11 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Pending DESI Program Proceedings – The List
11 Dec 2011, 4:44 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Apotex Cert Petition on 180-Day Exclusivity Forfeiture Decision is DOA, Says Teva in Opposition Brief
13 Dec 2010, 4:55 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/
New Study Examines Citizen Petitions; Concludes that Petitions are on the Rise and that 505(q) Has Been Unsuccessful
17 Jun 2012, 5:02 pm 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/
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/
OGD Finished 2010 on a High Note – Really High!
3 Feb 2011, 2:01 pm 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/
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/
Will the Hatch-Waxman Lock be Sprung in 2012?
7 Nov 2011, 1:07 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/