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Eleventh Circuit Rules Against the FTC in ANDROGEL Patent Settlement Appeal; Sen. Bingaman Pushes for Legislative Remedy
30 Apr 2012, 7:54 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA’s Third Annual Report to Congress on 505(q) Citizen Petitions; Agency Says the Jury is Still Out on the Petition Law, But There are Concerns
3 Apr 2012, 7:58 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Federal Circuit Reverses District Court Decision in Patent Delisting Counterclaim Case; All Orange Book Information is Not “Patent Information”
15 Apr 2010, 7:04 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Proposes to Clarify and Update Orphan Drug Regulations
19 Oct 2011, 3:30 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Brand-Name Side of the Exclusivity Equation; Exclusivity Under Fire
10 Sep 2012, 7:28 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The FAIR Generics Act Makes its Debut; the Bill Takes a New Tack in Addressing Patent Settlement Agreements
16 Nov 2011, 5:41 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House Bill
25 May 2012, 12:59 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
29 Feb 2012, 11:52 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Court Orders ANDA Approval in Pre-MMA 180-Day Exclusivity Case; Decision Appears to Have Post-MMA Implications
29 Oct 2012, 12:18 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Supreme Court Issues Decision on Generic Drug Preemption; To Borrow From Harry Caray – “Holy Cow! Generics Win! Generics Win!”
23 Jun 2011, 9:23 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review
30 Apr 2023, 8:00 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees
27 Jun 2017, 9:00 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
BMJ Article on Clinical Trial Reporting Foments Discontent on Capitol Hill (Our 1,500th Post!)
15 Feb 2012, 4:20 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Rules? Where We’re Going, We Don’t Need Rules: FDA Goes Back to the Future With Recent Hatch-Waxman Policy Shifts; What’s a Company to do?
2 Sep 2024, 5:52 pm by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
Another Advocacy Group Asks FDA to Increase Marketed Unapproved Drugs Enforcement Crackdown
12 Aug 2010, 12:25 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
ACI’s 12th Maximizing Pharmaceutical Patent Life Cycles Conference
3 Aug 2011, 10:41 am by FDABlog HPM
’s Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA Issues New Guidance on PDUFA User Fee Waivers, Reductions, and Refunds; Guidance Represents the Culmination of 18 Years of FDA Experience
21 Mar 2011, 12:00 pm by FDABlog HPM
Butler & Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act
10 Oct 2022, 6:51 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
“Product Hopping” Antitrust Lawsuit Takes on a Heightened Profile with Proposed FTC Amicus Brief
25 Nov 2012, 5:42 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
OGD Has Put the Brakes on ANDA Supplement Reviews; Will it Help Push Generic Drug User Fees Along?
16 Sep 2010, 11:43 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/