Search Results for:
Kurt R Karst
(277)
ARTICLES(277)
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The Ascension of FDA’s September 19, 2011 Marketed Unapproved Drugs Compliance Policy Guide
- June 05, 2014
- LEGAL ALERTS/ARTICLES
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After Years of Waiting, FDA Finally Lets Rip With Prescription PEG 3350 ANDA Withdrawal Proposal
- May 27, 2014
- LEGAL ALERTS/ARTICLES
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FDA Scores an Initial Win in COPAXONE Litigation; When Will the Other Shoe Drop?
- May 27, 2014
- LEGAL ALERTS/ARTICLES
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Mainers and FDC Act Preemption “In”, and PhRMA and Foreign Commerce Clause “Out” in Dispute Over Drug Importation Law
- May 27, 2014
- LEGAL ALERTS/ARTICLES
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William Mitchell Law Review Celebrates 30 Years of the Hatch-Waxman Amendments
- May 27, 2014
- LEGAL ALERTS/ARTICLES
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Teva Sues FDA Over Failure to Substantively Respond to COPAXONE Citizen Petition
- May 12, 2014
- LEGAL ALERTS/ARTICLES
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Enough Is Enough! Citizen Petition Issues a Clarion Call to FDA to Remove Ranbaxy’s Roadblock to Generic Competition on Several Drugs
- May 08, 2014
- LEGAL ALERTS/ARTICLES
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Boning Up: FDA Revisits Pre-MMA 180-Day Exclusivity and Addresses a New Scenario
- May 06, 2014
- LEGAL ALERTS/ARTICLES
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A Second Company Asks FDA to Reconsider Denial of NCE Exclusivity for Approved FDC . . . and to Stay Application of the Agency’s New Interpretation
- April 23, 2014
- LEGAL ALERTS/ARTICLES
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Zogenix Prevails in Initial Challenge to Massachusetts Emergency Order Banning ZOHYDRO ER
- April 21, 2014
- LEGAL ALERTS/ARTICLES
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FDA is Asked to Reconsider Denial of NCE Exclusivity for STRIBILD; Gilead Says FDA Erred in Not Applying the New (and Old) Interpretation
- April 15, 2014
- LEGAL ALERTS/ARTICLES
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Another REMS Antitrust Lawsuit: Mylan Sues Celgene Over THALOMID and REVLIMID to Obtain Drug Product Sample
- April 11, 2014
- LEGAL ALERTS/ARTICLES
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Zogenix Sues Massachusetts Over Order Banning ZOHYDRO ER; Alleges Ban is Unconstitutional
- April 11, 2014
- LEGAL ALERTS/ARTICLES
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A Second Lawsuit Tests the BPCIA Biosimilars “Patent Dance” Waters
- April 04, 2014
- LEGAL ALERTS/ARTICLES
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Independent Innovator and Repurposing Act Would Create New Patent Term Extension for Certain Biologics Patents
- March 28, 2014
- LEGAL ALERTS/ARTICLES
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Perrigo Sues FDA Over Failure to Grant Therapeutic Equivalence Rating for Testosterone Gel 505(b)(2) NDA
- March 28, 2014
- LEGAL ALERTS/ARTICLES
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Snowball Effect: The Incidence of Premature Paragraph IV Certification Notice Grows
- March 20, 2014
- LEGAL ALERTS/ARTICLES
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Amarin Sues FDA After the Agency Denies 5-Year NCE Exclusivity for VASCEPA
- March 12, 2014
- LEGAL ALERTS/ARTICLES
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Generic Drug Labeling Preemption: The Flavor of the Day
- March 12, 2014
- LEGAL ALERTS/ARTICLES
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Amarin Sues FDA After the Agency Denies 5-Year NCE Exclusivity for VASCEPA
- March 03, 2014
- LEGAL ALERTS/ARTICLES
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PLAN B Revisited: FDA Rules on One-Step Exclusivity and ANDA Labeling Carve-Outs
- February 28, 2014
- LEGAL ALERTS/ARTICLES
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BioMarin Snags the First Rare Pediatric Disease Priority Review Voucher with VIMIZIM Approval
- February 18, 2014
- LEGAL ALERTS/ARTICLES
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FDA Issues “Receipt Date” Guidance for Electronic Submissions; Make Your Submissions Before Midnight With Time to Spare
- February 14, 2014
- LEGAL ALERTS/ARTICLES
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The Rollout: FDA’s Mission Critical ANDA Undertaking
- February 14, 2014
- LEGAL ALERTS/ARTICLES
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AstraZeneca Wins One Battle, But Loses Another (And Perhaps the War) on SYMBICORT Patent Term Extension
- February 10, 2014
- LEGAL ALERTS/ARTICLES
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Broken Economic Incentives Require New Business Models for Antibiotics, Says CDC Antimicrobial Resistance Working Group Member
- February 10, 2014
- LEGAL ALERTS/ARTICLES
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GPhA Blasts FDA’s Generic Drug Labeling Proposal as Unworkable; Depicts a Dystopian Future
- February 10, 2014
- LEGAL ALERTS/ARTICLES