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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/
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/
The MDCO PTE Decision: In Play on Capitol Hill and in Action at the PTO
14 Jul 2011, 12:19 pm 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/
FTC Issues Long-Awaited Final Report on Authorized Generics; Report Examines Both the Short-Term Effects and Long-Term Impact on Competition and Drug Prices
31 Aug 2011, 12:30 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Gets the Ball Rolling on Biosimilar/Interchangeable Biological Product User Fee Program; Proposal Gives a Hat Tip to PDUFA While Acknowledging the Nascent State of the Industry
9 May 2011, 5:05 pm by FDABlog HPM
By 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/
McNeil Petitions the U.S. Supreme Court on OTC Drug Labeling Failure-to-Warn Preemption Issue
7 Dec 2010, 12:19 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Drug Purchasers Petition U.S. Supreme Court to Consider CIPRO Patent Settlement Case
8 Dec 2010, 10:42 am 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/
FDA Approval of Generic IMITREX STATdose Sheds Some Light on Auto-Injector “Sameness” Issues – But What About Other Combination Products?
8 Aug 2011, 5:18 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/
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/
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/
A court is permitted to add periods of cohabitation when determining the duration of the marital relationship, if one spouse was economically dependent upon the other during the period of cohabitation
8 Jul 2009, 5:22 am
Law Lessons from KURT CHRISTOPHER VS. [read post]
NJ Family Issues - http://www.kostrolaw.com/NJFamilyIssues
Tribute to Steve Shiffrin: Panel on First Amendment principles
24 Feb 2007, 11:47 pm
Panel on First Amendment Principles Moderator: Kurt Lash, Loyola Law School Los Angeles Keynote Address: Martin Redish, Northwestern University School of Law Opposing commercial speech protection is wrong and indeed pathological in regulating viewpoints. [read post]
43(B)log - http://tushnet.blogspot.com/
GAO Issues Report on Non-Inferiority Studies; Finds No Evidence of “Biocreep,” But More Conservative Use of Such Studies to Support Approval
30 Aug 2010, 11:53 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Federal Circuit Affirms Two District Court Decisions Concerning PTE Availability; Decisions Embrace an “Active Ingredient” Approach to PTEs
10 May 2010, 10:37 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Showdown Over AIA Section 37 Looms . . . .
14 Nov 2011, 4:46 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Outstanding Pre-FDAAA Citizen Petition Causes FDA to Rule Against 180-Day Exclusivity Forfeiture for Generic SKELAXIN
14 May 2010, 4:00 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/