Search Results for:
Kurt R Karst
(277)
- Page 9
ARTICLES(277)
-
New Jersey District Court Says ANDA Approval Delay and Patent Uncertainty Are Insufficient to Support DJ Jurisdiction in Generic DETROL LA Litigation
- November 14, 2011
- LEGAL ALERTS/ARTICLES
-
FDA Prevails in 10th Circuit Unapproved Morphine Sulfate Case; Court Does Not Reach Merits of Grandfather Claim
- November 08, 2011
- LEGAL ALERTS/ARTICLES
-
Burr Amendment to Senate FDA Approps Bill Seeks FDA Approval Time Transparency
- November 03, 2011
- LEGAL ALERTS/ARTICLES
-
California Court of Appeal Affirms Superior Court Decision that CIPRO Patent Settlement Agreements Do Not Violate State Antitrust Laws
- November 03, 2011
- LEGAL ALERTS/ARTICLES
-
PTO Says PTE Not Available in “Reverse Photocure” Case
- November 02, 2011
- LEGAL ALERTS/ARTICLES
-
Betelgeuse, Betelgeuse, Betelgeuse! The ANDA “RLD Theory of Liability” Rears Its Ugly Head
- October 31, 2011
- LEGAL ALERTS/ARTICLES
-
Sessions/Coburn Amendment to FDA Approps Bill Seeks To Effectively Nullify AIA Section 37 ANGIOMAX PTE Provision
- October 31, 2011
- LEGAL ALERTS/ARTICLES
-
VIAGRA Patent Decision Gives Rise to Dispute Over ANDA Approval, Concern About 180-Day Exclusivity Forfeiture; Court Rigidly Applies Patent Statute
- October 31, 2011
- LEGAL ALERTS/ARTICLES
-
FDA Proposes To Clarify and Update Orphan Drug Regulations
- October 21, 2011
- LEGAL ALERTS/ARTICLES
-
Lawsuit Seeks to Compel FDA Compliance with PDUFA User Fee Waiver Provisions
- October 17, 2011
- LEGAL ALERTS/ARTICLES
-
Office of Orphan Products Development SOPP Clarifies Orphan Drug Designation Policies
- October 17, 2011
- LEGAL ALERTS/ARTICLES
-
Landmark NORD Report on Orphan Drugs Authored By HP&M Director Shows FDA Flexibility in Approval
- October 12, 2011
- LEGAL ALERTS/ARTICLES
-
A Flurry of Generic Drug Labeling Carve-Out Citizen Petitions; Scorecard Updated
- October 04, 2011
- LEGAL ALERTS/ARTICLES
-
Rep. McCaul Seeks to Reinvigorate Interest in the Creating Hope Act of 2011; Introduces Companion Bill in the House
- October 03, 2011
- LEGAL ALERTS/ARTICLES
-
District Court Vacates 30-Month Stay Extension; Says Stay Only Applies to ANDAs Containing a Paragraph IV Certification
- September 29, 2011
- LEGAL ALERTS/ARTICLES
-
It Ain’t Over ‘Til It’s Over - The ANGIOMAX PTE Battle Takes Yet Another New Turn
- September 27, 2011
- LEGAL ALERTS/ARTICLES
-
GDUFA Negotiations Completed; Safety, Access, Transparency Are the Primary Aims Of the New Program
- September 26, 2011
- LEGAL ALERTS/ARTICLES
-
FDA Ramps Up Enforcement on Marketed Unapproved Human Drugs - Revised CPG Says New Products Will be Subject to Immediate Enforcement Action
- September 21, 2011
- LEGAL ALERTS/ARTICLES
-
Last-Ditch Effort to Jettison “The Dog Ate My Homework Act” from the America Invents Act Fails
- September 21, 2011
- LEGAL ALERTS/ARTICLES
-
USTR Embraces “TEAM” Approach in TPP Talks; Senators Back 12-Year Exclusivity for Biologics
- September 21, 2011
- LEGAL ALERTS/ARTICLES
-
Citizen Petition Requests Rulemaking Process for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions
- September 12, 2011
- LEGAL ALERTS/ARTICLES
-
FDA Issues Proposed PDUFA V Performance Goals & Procedures
- September 12, 2011
- LEGAL ALERTS/ARTICLES
-
NORD Petition Requests FDA Policy Statement on Orphan Drug Review Flexibility
- September 12, 2011
- LEGAL ALERTS/ARTICLES
-
Nevada State Court Judge Says There’s a Hole in Mensing Preemption for Some “Dear Doctor” Letters
- September 09, 2011
- LEGAL ALERTS/ARTICLES
-
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
- September 02, 2011
- LEGAL ALERTS/ARTICLES
-
Public Citizen Petitions FDA to Amend Generic Drug Labeling Regulations in the Wake of Mensing
- September 01, 2011
- LEGAL ALERTS/ARTICLES
-
Strength in Numbers? The Lobbying Push for a PTE
- August 23, 2011
- LEGAL ALERTS/ARTICLES
-
Tobacco Companies Sue FDA Over Graphic Warnings Rule
- August 22, 2011
- LEGAL ALERTS/ARTICLES
-
FDA Says Tenth Circuit Should Say Adieu to Grandfather Drug Case Without Much Ado; Not So Fast, Says Cody/Lannett
- August 17, 2011
- LEGAL ALERTS/ARTICLES