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FDA is Sued After Approving Generic Topical Corticosteroid Drug Products; Lawsuit Seeks Withdrawal or Suspension of ANDA Approvals
16 Nov 2011, 5:18 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
AstraZeneca Loses TRO Bid in Second Generic SEROQUEL Lawsuit
29 Mar 2012, 5:47 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Decision in Lannett THALOMID Bioequivalence Study Sample Antitrust Lawsuit Could Reignite Debate on Generic Drug Availability and REMS Restrictions
3 Apr 2011, 10:21 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Once Again Departs From Conventional Bioequivalence Metrics and Sets Partial AUC Parameters for Generic ADDERALL XR
24 Jun 2012, 11:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Revised Formula Yields a Lower Priority Review Voucher User Fee of $3,559,000; Will That Help Spark Greater Interest in the Program?
12 Sep 2012, 6:46 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
ISTA Sues FDA Over Generic XIBROM Approval, Says ANDA Approval Should Disappear in the Blink of An Eye
17 May 2011, 5:51 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Takes Another Hit in Court in Animal Feed Antibiotics Litigation; Court Says Agency’s Petition Denials Are Arbitrary and Capricious
6 Jun 2012, 8:52 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
AstraZeneca Sues FDA Over Generic SEROQUEL Labeling Carve-Out Issue After FDA Issues Non-Response Citizen Petition Denial
13 Mar 2012, 10:26 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
NJ District Court Punts in ASACOL DJ Action to Trigger 180-Day Exclusivity Forfeiture; Rules that Subsequent ANDA Applicant Lacks Standing
5 Apr 2011, 2:35 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Citizen Petition Requests Rulemaking Process for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions
6 Sep 2011, 4:00 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
NJ District Court Dismisses Patent Use Code Counterclaim as Not Valid Under Current Law; All Eyes Move to the Supreme Court PRANDIN Use Code Case
21 Nov 2011, 5:35 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Another Loss in Court for FDA; Judge Leon Rules for Death Row Inmates in Unapproved Thiopental Sodium Case
27 Mar 2012, 5:46 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Orange Book Patent Delisting Counterclaim Raised in 505(b)(2) Application Patent Infringement Litigation; Decision Could Provide Guidance on Drug Delivery System Patent Listability
8 Mar 2011, 12:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Academics Criticize the MMA’s Failure-to-Market Forfeiture Provisions as an Anemic Mechanism for Parked Exclusivity and the MMA’s DJ Provisions as a Paper Tiger
27 Apr 2011, 9:03 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Scope of New Chemical Entity Exclusivity and FDA’s “Umbrella” Exclusivity Policy
20 Jul 2011, 8:34 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Defendants Rack Up Another State Court Win in Mensing and RLD Liability Theory Decisions
8 May 2012, 5:59 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Wraps Up Responses to 2003 & 2004 Petitions on “Biosimilars”; Denies Outstanding Requests
16 Feb 2012, 5:56 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“RLD Theory of Liability” Continues to Fall Flat; Multiple Court Decisions Build Momentum in Generic Drug Failure-to-Warn Preemption Litigation
19 Mar 2012, 1:31 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Making the House FDA Reform Act of 2012 PAYGO Compliant – Are Expedited 505(q) Citizen Petition Responses the Answer?
28 May 2012, 2:21 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/