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Orphan Drug Designations and Applications Took Off in 2010 While Orphan Drug Approvals Tapered Off
31 Jan 2011, 2:03 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/
Buckman Preemption – The Good, The Bad, And The Ugly – And (This Just In) The Funky
27 Jan 2011, 5:00 am by Bexis
We’re returning to the topic of implied Buckman preemption today to discuss three recent decisions, Hughes v. [read post]
Drug and Device Law - http://druganddevicelaw.blogspot.com/
Another Week, Another Missive on BPCIA Exclusivity
26 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/
Reports Detail FDA’s 505(q) Citizen Petition Response Track Record; Section 505(q) May Have Some Unintended Consequences, FDA Says (Part II)
25 Jan 2011, 6:31 am 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/
Reports Detail FDA’s 505(q) Citizen Petition Response Track Record; Section 505(q) May Have Some Unintended Consequences, FDA Says (Part I)
24 Jan 2011, 4:27 am 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/
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/
High Court Denies Apotex Petition on 180-Day Exclusivity
18 Jan 2011, 7:42 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Apotex Seeks to Trigger 180-Day Exclusivity for Generic LEXAPRO Tablets
17 Jan 2011, 9:27 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
PTO Sued After Denying “Mildly Tardy” Second Interim PTE Request
12 Jan 2011, 10:02 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/
Reverse Payment Settlements Return to the Supreme Court
10 Jan 2011, 11:49 am by Dennis Crouch
" Documents: Kurt Karst from the FDA Law Blog Law Professor Brief   [read post]
Patently-O - http://www.patentlyo.com/patent/
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/
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/
BPCIA’s Principal Authors Seek to Clarify Congressional Intent With Respect to 12-Year Exclusivity Period; PhRMA/BIO Request “Umbrella Exclusivity”
5 Jan 2011, 8:11 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Here We Go Again . . . . Amphastar Renews Generic LOVENOX Case Against FDA
30 Dec 2010, 5:48 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
U.S. Supreme Court Petitioned to Review Federal Circuit Patent Use Code Decision
28 Dec 2010, 10:58 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Sandoz Requests 180-Day Exclusivity Forfeiture Decision for Generic HECTOROL
21 Dec 2010, 11:00 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/