Search for: "Kurt Karst" Results 101 - 120 of 371
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FTC Commissioner Objects to Certain Provisions in Senate FDA User Fee Reauthorization Legislation
5 Jun 2012, 7:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Orange Book Patent Listing Precipitates DJ Action to Trigger Generic KEPPRA XR 180-Day Exclusivity Forfeiture
28 Mar 2011, 2:42 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Senate and House Bills Seek to Legislatively Overturn the Supreme Court’s Mensing Decision
19 Apr 2012, 7:08 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Landmark NORD Report on Orphan Drugs Authored By HP&M Director Shows FDA Flexibility in Approval
11 Oct 2011, 1:53 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Supreme Court Rules in Patent Use Code Case; Reverses Federal Circuit Decision
17 Apr 2012, 5:55 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Fifth Circuit Vacates District Court “Second Inspection Ruling” in Compounding Pharmacy Case
28 Feb 2011, 3:53 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Coda in the ANGIOMAX Symphony; Approaching Fine (the End)
9 Feb 2012, 4:06 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Proposes to Depart From Conventional Bioequivalence Metrics; Draft Guidance Proposes Partial AUC for Generic RITALIN LA
30 Nov 2011, 5:07 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New Study Examines Citizen Petitions; Concludes that Petitions are on the Rise and that 505(q) Has Been Unsuccessful
17 Jun 2012, 5:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Revelations: FDA’s Perspective on Drugs Marketed Pursuant to a Pending DESI Proceeding and the Unapproved Drugs CPG
14 Dec 2011, 6:03 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
You Had Us At “Biosimilars,” FDA; Agency Ties Up Yet Another Biosimilars Loose End With Petition Response Concerning Certain “Biological Drugs”
21 Mar 2012, 5:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Nevada State Court Judge Says There’s a Hole in Mensing Preemption for Some “Dear Doctor” Letters
5 Sep 2011, 2:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Other Shoe Drops: ViroPharma Sues FDA – Challenges Denial of 3-Year Exclusivity and ANDA Approvals
16 Apr 2012, 1:29 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Announces Major Enforcement Action on Marketed Unapproved Prescription Cough, Cold, and Allergy Drug Products
2 Mar 2011, 10:27 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Obesity Epidemic: FDA’s Growing Waistline!
3 Sep 2012, 2:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Denies Citizen Petition on Generic COMBIVIR 180-Day Exclusivity “First Applicant” Issue
1 Jun 2011, 5:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
ULTRA Bill Introduced in the House; Legislation Seeks to Permit Broader Use of Scientific Data to Support Surrogate Endpoints for “Ultra Orphan” Drug Approvals
2 Jan 2012, 6:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Public Citizen Petitions FDA to Amend Generic Drug Labeling Regulations in the Wake of Mensing
29 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 Completes Implementation of Affordable Care Act Sec. 10609 “Generic Loophole” Provisions
12 May 2011, 7:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Preserve Access to Affordable Generics Act Resurfaces Early in the 112th Congress
30 Jan 2011, 11:20 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/