Search Results for:
Kurt R Karst
(277)
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ARTICLES(277)
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Lawmakers Express “Grave Concerns” with Generic Drug Labeling Proposal; Demand Answers from FDA
- January 28, 2014
- LEGAL ALERTS/ARTICLES
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Improving the Yield on ANDA Submissions: FDA Wants to Hear Industry’s Concerns and Provide Guidance on How to Build a Better ANDA
- January 27, 2014
- LEGAL ALERTS/ARTICLES
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FDA Seeks Comment on Generic Dexmedetomidine HCl Injection (PRECEDEX) Approval
- January 17, 2014
- LEGAL ALERTS/ARTICLES
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OOPD Clarifies Orphan Drug Designation Policies for Scleroderma and Pulmonary Hypertension
- January 17, 2014
- LEGAL ALERTS/ARTICLES
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Weekend and Holiday ANDA Tentative (or Final) Approvals and 180-Day Exclusivity: We Won’t Know if Anyone is Swimming Naked Until the Tide Goes Out!
- January 17, 2014
- LEGAL ALERTS/ARTICLES
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DC Circuit Reinstates KV Lawsuit Over MAKENA and Compounded 17p in Light of Cook Decision and DQSA
- January 13, 2014
- LEGAL ALERTS/ARTICLES
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The Federal Circuit is Slated to Consider an Appeal of the First BPCIA Biosimilars “Patent Dance” Decision
- January 08, 2014
- LEGAL ALERTS/ARTICLES
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The Federal Circuit Wades into FDC Act Preemption and Intended Use in RevitaLash Decision
- January 06, 2014
- LEGAL ALERTS/ARTICLES
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Office of Generic Drugs “Super Office” Becomes a Reality; New “Office of Generic Drug Policy” Will Handle Hatch-Waxman Issues
- December 30, 2013
- LEGAL ALERTS/ARTICLES
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Amgen Advocates for Distinguishable Non-Proprietary Names in Substantial Comments to GPhA and Novartis Biosimilar Naming Citizen Petitions
- December 27, 2013
- LEGAL ALERTS/ARTICLES
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Royal Flush? Trade Groups Challenge a Second Drug Stewardship Program; This Time the Target is King County, Washington
- December 19, 2013
- LEGAL ALERTS/ARTICLES
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ADAPT Act Would Create a New Limited Population Approval Pathway for Antibiotics and Antifungals
- December 16, 2013
- LEGAL ALERTS/ARTICLES
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Breaking the Silence: Rush Bill Would Curb Drug Patent Settlement Agreements
- December 16, 2013
- LEGAL ALERTS/ARTICLES
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Diary of a Hatch-Waxman Addict: Day 3,655 - What About Untimely (Late) Notice?
- December 13, 2013
- LEGAL ALERTS/ARTICLES
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Otsuka Alleges Premature Notice From a Repeat Offender in SAMSCA Patent Infringement Case
- December 11, 2013
- LEGAL ALERTS/ARTICLES
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Escape Hatch: New Legislation Seeks to Provide a Way Out for Some Companies Subject to GDUFA User Fees
- December 05, 2013
- LEGAL ALERTS/ARTICLES
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FDA is Petitioned Twice More to Delay Start of Hatch-Waxman Exclusivity
- December 05, 2013
- LEGAL ALERTS/ARTICLES
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FDA Enters Into Consent Decree; Agrees to Timely Complete Triclosan OTC Drug Antiseptic Monographs
- December 03, 2013
- LEGAL ALERTS/ARTICLES
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One Sponsor’s Failure is Another Sponsor’s Fortune: The Importance of Timely Listing (and Challenging) Orange Book Patents
- November 27, 2013
- LEGAL ALERTS/ARTICLES
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PTO Dismisses PTE Application in “Reverse Photocure” Case; Moves One Step Closer to a Showdown in Court?
- November 26, 2013
- LEGAL ALERTS/ARTICLES
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Sanofi Sues FDA to Prevent Disclosure of OTC NASACORT Labeling Before Product Launch; Claims FOIA Exemption 4
- November 08, 2013
- LEGAL ALERTS/ARTICLES
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Game of Thrones: FDA is Once Again Petitioned on Biosimilar Naming; Novartis Wants Shared INNs
- November 01, 2013
- LEGAL ALERTS/ARTICLES
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FDA Prevails in Challenge to Generic ACETADOTE Approval; Court Grants Summary Judgment
- October 29, 2013
- LEGAL ALERTS/ARTICLES
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FDA Largely Denies Citizen Petition on Single, Shared REMS System, But Outlines Agency Standards and Processes
- October 22, 2013
- LEGAL ALERTS/ARTICLES
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FDA’s House Rules on 505(b)(2) NDA Choice of Listed Drug; How Does it Affect Dealer’s Choice?
- October 21, 2013
- LEGAL ALERTS/ARTICLES
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Repairing the U.S. Cancer Care Delivery System: Should It Include a New Exclusivity Incentive?
- October 21, 2013
- LEGAL ALERTS/ARTICLES
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Biosimilar Substitution Bill Opposition Strikes Gold in California: Governor Brown Vetoes the Measure
- October 16, 2013
- LEGAL ALERTS/ARTICLES
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As Maine’s Drug Importation Law Goes Into Effect, State Seeks Dismissal of Lawsuit to Block Implementation
- October 11, 2013
- LEGAL ALERTS/ARTICLES
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The Shutdown: An Update on FDA Activities
- October 08, 2013
- LEGAL ALERTS/ARTICLES
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As Partial Government Shutdown Kicks In, FDA’s Foods Program Is Hardest Hit
- October 03, 2013
- LEGAL ALERTS/ARTICLES