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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/
Senator Cites Ethical “Defect” in Biosimilars Law Exclusivity Provisions; Proposes Legislative Fix
4 Nov 2010, 10:09 am 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/
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/
New Jersey District Court Denies Preliminary Injunction Motion in Generic CARBATROL Pre-MMA 180-Day Exclusivity Case; An Appeal Quickly Follows
7 Jul 2011, 3:38 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Coming 505(q) Citizen Petition Cliff and Some Interesting Petition Strategies
4 Sep 2012, 6:38 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/
Efforts to Obtain a PTE for ANGIOMAX Patent Continue as the U.S. House Passes an Amendment to the America Invents Act in “After Business Hours” Vote
28 Jun 2011, 2:03 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/
A New Hatch-Waxman DJ Jurisdiction Decision . . . . And an Added Twist
24 Jan 2012, 6:34 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA is Sued Over Generic CARBATROL; Lawsuit Challenges FDA Decisions on Pre-MMA 180-Day Exclusivity
30 May 2011, 6:34 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
“Bring Out Your Dead” Says OGD in a Pre-GDUFA House Cleaning Move as the Agency Prepares for ANDAgeddon
13 Jun 2012, 10:31 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Burr Amendment to Senate FDA Approps Bill Seeks FDA Approval Time Transparency
2 Nov 2011, 10:14 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Prevails in 10th Circuit Unapproved Morphine Sulfate Case; Court Does Not Reach Merits of Grandfather Claim
6 Nov 2011, 10:57 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Here It Goes, Here It Goes, Here It Goes Again: The Build Back Better Act (Redux)
13 Jul 2022, 10:39 pm by Kurt R. Karst
Koblitz & Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
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/
The YASMIN Case: Is it Conceivable (or Not) that Hatch-Waxman Method Patent Infringement Lawsuits are Limited to Information in the “Indications and Usage” Drug Labeling Section?
22 Feb 2012, 5:49 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA
19 Sep 2023, 3:34 am by Kurt R. Karst
Koblitz & Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
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/
Court Dismisses, on Ripeness Grounds, Cephalon Challenge to Generic FENTORA Approval
18 Jul 2011, 5:16 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/