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Oral Argument in the Mensing-Demahy Generic Drug Labeling Preemption Case
30 Mar 2011, 5:32 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
IOM Issues Report on Rare Diseases and Orphan Products; Recommends an Integrated National Strategy
7 Oct 2010, 10:14 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Year of the Orphan; Orphan Drug Designations and Approvals Hit All-Time High in 2011
8 Feb 2012, 4:16 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New Director Tapped to Head FDA’s Office of Generic Drugs
13 Jul 2012, 4:03 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Judge Snuffs Out Holistic Candlers Lawsuit; Constitutional Challenge Falls on Deaf Ears
20 Mar 2011, 10:10 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
HP&M Counsel John Claud Provides Testimony to House Subcommittee on FDA Foreign Inspections
6 Feb 2024, 7:39 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
FDA Takes Action on LOVENOX Citizen Petition and Approves Sandoz ANDA
23 Jul 2010, 10:55 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Drug Shortage Prevention Act Seeks to Improve Communication and Expedite Review of Drugs in Shortage
3 Feb 2012, 1:18 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Flare-Up Over Generic Herpes Drug Could be Short-Lived
27 Sep 2010, 12:59 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Senator Nelson Takes Another Crack at the Drug Price Competition Act
16 Jun 2010, 10:30 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Patent Settlement Agreements Remain in the Spotlight, But Not the Unified Spotlight the FTC Might Want
15 Nov 2011, 2:10 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Pfizer Withdraws Subpart H Drug MYLOTARG From the Market
22 Jun 2010, 2:12 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
UPDATE - Generic Drug Labeling Carve-Out Citizen Petition Scorecard
4 Aug 2010, 3:45 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
All Eyes are on APP’s Intervention Motion as the Government Bows Out of ANGIOMAX PTE Litigation
9 Sep 2010, 6:28 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Advocacy Groups Ask FDA to Further Crack Down on Marketed Unapproved Drugs
20 Apr 2010, 12:06 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Put it on Mr. Underhill’s Bill! FDA Sets Priority Review Voucer Redemption Fee at Almost $4.6 Million
14 Sep 2010, 1:23 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Dog Ate My Homework Butt-Saving Bill to be Slipped into the Patent Reform Act
8 Aug 2007, 8:19 am
Kurt Karst of the FDA Law Blog ran a nice update on patent term extension (PTE) legislation. [read post]
Patent Baristas - http://www.patentbaristas.com
House Passes FDA Reform Act of 2012; Next Up – Conference Committee
31 May 2012, 10:05 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Provisions to Promote Approval of Rare and Neglected Disease Products Survive Chopping Block in the Senate’s FY11 Omnibus Approps Bill
15 Dec 2010, 1:44 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Presidential Commission Seeks Comment on the Development of Medical Countermeasures for Children
28 Jun 2012, 8:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/