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PTO Says PTE Not Available in “Reverse Photocure” Case
31 Oct 2011, 5:40 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
FDA, in a RARE Act, Takes To Lobbying for a Change to the Orphan Drug Act
17 May 2022, 7:18 am by Kurt R. Karst
By Kurt R. [read post]
FDA Law Blog - https://www.thefdalawblog.com/
New Bill Would Change Clinical Trial Registry Reporting Requirements and Enforcement Measures for Studies Supported by Federal Grants
3 May 2012, 5:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Citizen Petition Requests Rulemaking Process for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions
6 Sep 2011, 4:00 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
BPCIA’s Principal Authors Seek to Clarify Congressional Intent With Respect to 12-Year Exclusivity Period; PhRMA/BIO Request “Umbrella Exclusivity”
5 Jan 2011, 8:11 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Strength in Numbers? The Lobbying Push for a PTE
21 Aug 2011, 6:49 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 Withdraws Avastin Breast Cancer Indication Approval
22 Nov 2011, 7:51 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New Reports on FDA Drug Approval Performance Emerge as House Committee Considers User Fee Reauthorization Legislation
10 May 2012, 11:14 am 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/
Blown 30-Month ANDA Tentative Approval and Approval Dates – A Growing Industry Concern; Is Litigation in the Works?
11 May 2010, 4:00 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Relinquishment and Waiver of 180-Day Exclusivity Post-MMA; What is FDA Precedent and Where Might FDA be Headed?
14 Jun 2010, 1:07 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
New Analysis Takes Issue with CBO Patent Settlement Legislation Cost Estimate
16 Aug 2010, 8:10 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
On the Eve of PDUFA Reauthorization, DC District Court Strikes Down FDA Interpretation of PDUFA
25 Jun 2012, 8:53 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
D.C. District Court Denies Preliminary Injunction in Generic LOVENOX Case; Is the Juice Worth the Squeeze for Sanofi to Appeal?
26 Aug 2010, 10:01 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Graceway Sues FDA Over Generic ALDARA Cream Decisions; Alleges that Petition Response is Contrary to Basic Science, Common Sense, and Precedent
13 Jul 2010, 12:02 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Federal Circuit Denies Rehearing Petition in LEVAQUIN Patent Term Extension Case
19 Jul 2010, 1:12 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
District Court Decision Sidesteps 30-Month Stay Tolling Issue; Denies Patent Infringement Litigation Stay
19 Apr 2010, 1:34 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
Novartis Sues FDA Over Generic FAMVIR; Alleges that FDA Failed to Require a Split Certification
23 Sep 2010, 12:39 pm by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/
In Litigation Over Animal Feed Antibiotic Withdrawals, District Court Says FDA Needs to Move Forward
22 Aug 2012, 3:02 am by FDABlog HPM
By Kurt R. [read post]
FDA Law Blog - http://www.fdalawblog.net/fda_law_blog_hyman_phelps/