Search Results for:
Kurt R Karst
(277)
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ARTICLES(277)
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FDA Flexes GDUFA Enforcement Muscle; Issues First Warning Letter to Non-Compliant Manufacturing Facility
- October 03, 2013
- LEGAL ALERTS/ARTICLES
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Money Has a Way of Changing People: The UFAization of FDA's Office of Generic Drugs
- September 27, 2013
- LEGAL ALERTS/ARTICLES
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Act II, Scene II: A Rose By Any Other Name Would Smell as Sweet? “No!” Says GPhA in Citizen Petition to FDA on Biosimilar Naming
- September 23, 2013
- LEGAL ALERTS/ARTICLES
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“You Can’t Handle the Truth!” Code Orange: Court Dismisses Lanham Act-Orange Book Therapeutic Equivalence Rating Complaint on Primary Jurisdiction Grounds
- September 17, 2013
- LEGAL ALERTS/ARTICLES
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Not In Our Backyard! Pharmacists and Trade Groups Sue to Block Implementation of Maine Drug Importation Law
- September 14, 2013
- LEGAL ALERTS/ARTICLES
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Alameda County Drug Take-Back and Disposal Ordinance Not Unconstitutional Says Federal Judge
- September 05, 2013
- LEGAL ALERTS/ARTICLES
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Lifting the Veil on FDA Subpart H Surrogate Endpoint Approvals
- August 29, 2013
- LEGAL ALERTS/ARTICLES
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Public Shaming: FDA Edges Closer to Citizen Petition Denial for Intent to Delay Generic Drug Approval, But Prefers to Pass the Buck on Enforcement
- August 29, 2013
- LEGAL ALERTS/ARTICLES
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An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing Directions
- August 28, 2013
- LEGAL ALERTS/ARTICLES
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First Post-FDAAA “New Active Ingredient” Election and Grant of NCE Exclusivity Made With the Approval of FETZIMA
- August 28, 2013
- LEGAL ALERTS/ARTICLES
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Eisai Says FDA Erroneously Triggered NCE Exclusivity Start Dates Before DEA Controlled Substance Scheduling Permitted Marketing
- August 14, 2013
- LEGAL ALERTS/ARTICLES
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New Legislation Seeks to Provide 5-Year NCE Exclusivity For Certain Combination Drugs
- August 07, 2013
- LEGAL ALERTS/ARTICLES
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Superior Court of Pennsylvania Delivers Quadruple Whammy in Metoclopramide Failure-to-Warn Preemption Decisions; Gives RLD Theory of Liability Some Legs
- August 01, 2013
- LEGAL ALERTS/ARTICLES
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FDA Resolves 180-Day Exclusivity Forfeiture for Tentative Approvals that Occur on the 30-Month ANDA Submission Anniversary Date
- July 29, 2013
- LEGAL ALERTS/ARTICLES
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FDA Racks Up a Circuit Court Loss in Imported and Unapproved Thiopental Sodium Case; Will It Jeopardize FDA’s Drug Shortage Program?
- July 25, 2013
- LEGAL ALERTS/ARTICLES
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FDA SOS: New Bill Would Exempt FDA User Fees From the Ravages of Sequestration
- July 19, 2013
- LEGAL ALERTS/ARTICLES
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A Punt Return, Not a Fumble Return, in the Second FDA Resolution of a 180-Day Exclusivity Punt Case
- July 18, 2013
- LEGAL ALERTS/ARTICLES
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Lies, Damned Lies, and Statistics: Another Report on Drug Patent Settlement Agreements
- July 16, 2013
- LEGAL ALERTS/ARTICLES
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New IMS Report Ups the Ante on Drug Patent Settlement Agreement Savings
- July 11, 2013
- LEGAL ALERTS/ARTICLES
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FDA Moves to Blunt the Effects of the Supreme Court’s Mensing and Bartlett Generic Drug Preemption Decisions
- July 08, 2013
- LEGAL ALERTS/ARTICLES
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In an Unusual Move, FDA Denies RLD Designation for an Orange Book Listed Drug
- July 08, 2013
- LEGAL ALERTS/ARTICLES
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FDA Precedent on Tramadol NDA Resubmission Shows Agency Efforts to Dull the Pain of a Statutory Prohibition
- July 04, 2013
- LEGAL ALERTS/ARTICLES
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Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!
- June 28, 2013
- LEGAL ALERTS/ARTICLES
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House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action Deadlines
- June 14, 2013
- LEGAL ALERTS/ARTICLES
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Obama Administration Gives Up Fight Over PLAN B After Second Circuit Issues Split Decision on Motion for Stay Pending Appeal
- June 13, 2013
- LEGAL ALERTS/ARTICLES
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A Fumble Return, Not a Punt Return, in the First FDA Resolution of a 180-Day Exclusivity Punt Case
- June 07, 2013
- LEGAL ALERTS/ARTICLES
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Momenta Spars with Amphastar; Says Federal Circuit’s LOVENOX Safe Harbor Decision Must be Taken Up by the Supreme Court
- June 06, 2013
- LEGAL ALERTS/ARTICLES