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GAO Report Criticizes FDA on Antibiotic Labeling; Finds No Evidence of Encouraged Innovation
1 Feb 2012, 1:22 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
VIAGRA Patent Decision Gives Rise to Dispute Over ANDA Approval, Concern About 180-Day Exclusivity Forfeiture; Court Rigidly Applies Patent Statute
24 Oct 2011, 1:39 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/
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 Sued for Abrogating MAKENA Orphan Drug Exclusivity; Suit Alleges that FDA is Turning a Blind Eye to Compounded 17P and Bowing to Political Pressure
8 Jul 2012, 7:01 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Says Tenth Circuit Should Say Adieu to Grandfather Drug Case Without Much Ado; Not So Fast, Says Cody/Lannett
15 Aug 2011, 6:20 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
First Dust Up Over Generic PROVIGIL 180-Day Exclusivity Quickly Put on Hold With TRO/PI Motion Withdrawal, But is Followed Up With a Second Lawsuit
5 Apr 2012, 1:41 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
GAO Report Finds BPCA and PREA to be Ongoing Successes, But Says that FDA Needs to Improve Tracking of Products Studied for Pediatric Uses
6 Jun 2011, 5:21 pm by FDABlog HPM
Shah & Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
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/
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/
A Flurry of Amicus Briefs Filed in the K-DUR Patent Settlement Appeal Seek a Reversal of a New Jersey District Court Decision
23 May 2011, 1:54 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Flexes New Enforcement Muscle; Issues Warning Letter for Failure to Meet Required Postmarketing Study Milestone Dates
28 Feb 2012, 7:42 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Is Information Contained in a Paragraph IV Certification Notice Letter Accompanied by an Offer of Confidential Access Subject to Public Disclosure? One District Court has an Answer
29 Jun 2011, 8:15 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Simultaneously Qualifying for and Forfeiting 180-Day Exclusivity Eligibility for Failure to Obtain Timely Tentative Approval
12 Apr 2011, 2:47 pm 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/
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/
FDA Announces Intent to Take Enforcement Action With Respect to Certain Marketed Unapproved Oxycodone Drug Products; Denies Lannett “Grandfather” Drug Petition
5 Jul 2012, 9:03 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
ANGIOMAX – The Other Patent Battle
11 Aug 2011, 5:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
A Federal Court Win on the RLD Theory of Liability; More of Moore Will Likely be Called For
9 Jan 2012, 6:24 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17P
6 Sep 2012, 5:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/