Search Results for:
Kurt R Karst
(277)
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ARTICLES(277)
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The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not Warranted
- September 21, 2012
- LEGAL ALERTS/ARTICLES
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Patent Settlement Agreements: The Next Barrage
- September 19, 2012
- LEGAL ALERTS/ARTICLES
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Revised Formula Yields a Lower Priority Review Voucher User Fee of $3,559,000; Will That Help Spark Greater Interest in the Program?
- September 17, 2012
- LEGAL ALERTS/ARTICLES
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The Brand-Name Side of the Exclusivity Equation; Exclusivity Under Fire
- September 14, 2012
- LEGAL ALERTS/ARTICLES
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KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17P
- September 10, 2012
- LEGAL ALERTS/ARTICLES
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The Coming 505(q) Citizen Petition Cliff and Some Interesting Petition Strategies
- September 10, 2012
- LEGAL ALERTS/ARTICLES
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Hot Ticket Item - Patent Settlement Agreement Challenges
- September 04, 2012
- LEGAL ALERTS/ARTICLES
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Congressional Interest in FDA Remains High, Even After the Enactment of FDASIA
- August 22, 2012
- LEGAL ALERTS/ARTICLES
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In Litigation Over Animal Feed Antibiotic Withdrawals, District Court Says FDA Needs to Move Forward
- August 22, 2012
- LEGAL ALERTS/ARTICLES
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Push for 12-Year Biologics Exclusivity in TPP Agreement Continues as the Next Round of Negotiations Approaches
- August 20, 2012
- LEGAL ALERTS/ARTICLES
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FDA is Sued Again Over Pre-MMA 180-Day Exclusivity; This Time the Drug is Generic ACTOS
- August 16, 2012
- LEGAL ALERTS/ARTICLES
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Running Into a Glass Door (or Window); a Problem With the New “Window ANDA” Forfeiture Provision
- August 14, 2012
- LEGAL ALERTS/ARTICLES
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FDA Rescinds Orphan Drug Exclusivity for Wilate; A First-of-its-Kind Decision
- August 13, 2012
- LEGAL ALERTS/ARTICLES
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Federal Circuit Rules That Hatch-Waxman “Safe Harbor” is Quite Broad in Dispute Over Enoxaparin Method Patent
- August 10, 2012
- LEGAL ALERTS/ARTICLES
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“Big RLD” Versus “Little rld” - What’s the Difference?
- August 08, 2012
- LEGAL ALERTS/ARTICLES
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Supreme Court Asked to Take Up Post-Mensing Bartlett Generic Drug Labeling Preemption Decision
- August 03, 2012
- LEGAL ALERTS/ARTICLES
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STOPP Act Would Establish New Requirements for Tamper-Resistant Drugs
- July 30, 2012
- LEGAL ALERTS/ARTICLES
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New Director Tapped to Head FDA’s Office of Generic Drugs
- July 19, 2012
- LEGAL ALERTS/ARTICLES
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DC District Court Rules for FDA in Generic SEROQUEL Exclusivity Case; Grants Motion for Summary Judgment
- July 12, 2012
- LEGAL ALERTS/ARTICLES
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FDA Petitioned on 180-Day Exclusivity Forfeiture for Tentative Approvals that Occur on the 30-Month ANDA Submission Anniversary Date
- July 04, 2012
- LEGAL ALERTS/ARTICLES
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Presidential Commission Seeks Comment on the Development of Medical Countermeasures for Children
- July 04, 2012
- LEGAL ALERTS/ARTICLES
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On the Eve of PDUFA Reauthorization, DC District Court Strikes Down FDA Interpretation of PDUFA
- June 27, 2012
- LEGAL ALERTS/ARTICLES
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FDA Once Again Departs From Conventional Bioequivalence Metrics and Sets Partial AUC Parameters for Generic ADDERALL XR
- June 25, 2012
- LEGAL ALERTS/ARTICLES
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A 505(b)(2) NDA in Search of a Basis for Submission and Approval; the Curious Case of Morphine Sulfate Oral Solution
- June 23, 2012
- LEGAL ALERTS/ARTICLES
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When Can’t a “Listed Drug” Serve as a Reference Product for a 505(b)(2) Application?
- June 21, 2012
- LEGAL ALERTS/ARTICLES
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House Passes Bill to Repeal Medical Device Excise Tax; Veto Threat Looms
- June 11, 2012
- LEGAL ALERTS/ARTICLES
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FDA Takes another Hit in Court in Animal Feed Antibiotics Litigation; Court Says Agency’s Petition Denials Are Arbitrary and Capricious
- June 08, 2012
- LEGAL ALERTS/ARTICLES
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FTC Commissioner Objects to Certain Provisions in Senate FDA User Fee Reauthorization Legislation
- June 07, 2012
- LEGAL ALERTS/ARTICLES