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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/
FDA Denies ViroPharma Citizen Petition and Approves Generic VANCOCIN; ViroPharma Lawsuit to Follow
10 Apr 2012, 3:53 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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/
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/
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/
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/
Senators Vigorously Object to the Inclusion of Patent Settlement Provisions in FY 2011 Appropriations Bill
21 Sep 2010, 8:58 am 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/
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/
After a Hiatus, the BLOCKING Act is Back!
11 Dec 2024, 10:38 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
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/
Another Push to Legislatively Overturn Forest Group False Marking Decision
11 Oct 2010, 12:59 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
PDUFA IV User Fees End With a Bang, Not a Whimper! Application Fee Increases by a Whopping 19.4% (or Almost $300K)
31 Jul 2011, 5:03 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/
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/
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/
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/
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/
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/
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/