Search Results for:
Kurt R Karst
(277)
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ARTICLES(277)
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House Passes FDA Reform Act of 2012; Next Up - Conference Committee
- June 01, 2012
- LEGAL ALERTS/ARTICLES
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Pennsylvania District Court Issues an XL Decision in WELLBUTRIN XL Antitrust, Sham Citizen Petition Case
- June 01, 2012
- LEGAL ALERTS/ARTICLES
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Making the House FDA Reform Act of 2012 PAYGO Compliant - Are Expedited 505(q) Citizen Petition Responses the Answer?
- May 30, 2012
- LEGAL ALERTS/ARTICLES
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U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House Bill
- May 30, 2012
- LEGAL ALERTS/ARTICLES
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FDA’s PLAIR Program Collides With Hatch-Waxman
- May 25, 2012
- LEGAL ALERTS/ARTICLES
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Defendants Rack Up Another State Court Win in Mensing and RLD Liability Theory Decisions
- May 09, 2012
- LEGAL ALERTS/ARTICLES
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New Bill Would Change Clinical Trial Registry Reporting Requirements and Enforcement Measures for Studies Supported by Federal Grants
- May 07, 2012
- LEGAL ALERTS/ARTICLES
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Eleventh Circuit Rules Against the FTC in ANDROGEL Patent Settlement Appeal; Sen. Bingaman Pushes for Legislative Remedy
- May 01, 2012
- LEGAL ALERTS/ARTICLES
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Senate and House Bills Seek to Legislatively Overturn the Supreme Court’s Mensing Decision
- April 24, 2012
- LEGAL ALERTS/ARTICLES
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Absolutely, Totally, and in All Other Ways Inconceivable? Nope, Says the Federal Circuit in YASMIN Hatch-Waxman Method Patent Litigation
- April 19, 2012
- LEGAL ALERTS/ARTICLES
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Supreme Court Rules in Patent Use Code Case; Reverses Federal Circuit Decision
- April 19, 2012
- LEGAL ALERTS/ARTICLES
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The Other Shoe Drops: ViroPharma Sues FDA - Challenges Denial of 3-Year Exclusivity and ANDA Approvals
- April 16, 2012
- LEGAL ALERTS/ARTICLES
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FDA Denies Viropharma Citizen Petition and Approves Generic VANCOCIN; Viropharma Lawsuit to Follow
- April 12, 2012
- LEGAL ALERTS/ARTICLES
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First Dust Up Over Generic PROVIGIL 180-Day Exclusivity Quickly Put on Hold With TRO/PI Motion Withdrawal, But is Followed Up With a Second Lawsuit
- April 10, 2012
- LEGAL ALERTS/ARTICLES
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FDA’s Third Annual Report to Congress on 505(q) Citizen Petitions; Agency Says the Jury is Still Out on the Petition Law, But There are Concerns
- April 05, 2012
- LEGAL ALERTS/ARTICLES
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Pallone Bill Takes an “Oscar Rogers Approach” to 180-Day Exclusivity Forfeiture and FDA’s Office of Generic Drugs: FIXIT!
- April 04, 2012
- LEGAL ALERTS/ARTICLES
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AstraZeneca Loses TRO Bid in Second Generic SEROQUEL Lawsuit
- March 30, 2012
- LEGAL ALERTS/ARTICLES
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Leahy Bill Would Legislatively Undo the U.S. Supreme Court’s Mensing Decision
- March 30, 2012
- LEGAL ALERTS/ARTICLES
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Another Loss in Court for FDA; Judge Leon Rules for Death Row Inmates in Unapproved Thiopental Sodium Case
- March 29, 2012
- LEGAL ALERTS/ARTICLES
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D.C. District Court Denies Preliminary Injunction In Generic SEROQUEL Litigation; Dismisses "Premature" Lawsuit Without Prejudice
- March 27, 2012
- LEGAL ALERTS/ARTICLES
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Nonprofit Groups Prevail in Lawsuit Against FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal Feed
- March 27, 2012
- LEGAL ALERTS/ARTICLES
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FDA Issues Draft MDUFA Performance Goals and Procedures
- March 26, 2012
- LEGAL ALERTS/ARTICLES
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Supreme Court Decision Raises Interesting Questions Regarding Judicial Review of Agency Action, Provides Few Answers
- March 26, 2012
- LEGAL ALERTS/ARTICLES
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You Had Us at "Biosimilars," FDA; Agency Ties Up Yet another Biosimilars Loose End with Petition Response Concerning Certain "Biological Drugs"
- March 23, 2012
- LEGAL ALERTS/ARTICLES
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“RLD Theory of Liability” Continues to Fall Flat; Multiple Court Decisions Build Momentum in Generic Drug Failure-to-Warn Preemption Litigation
- March 21, 2012
- LEGAL ALERTS/ARTICLES
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AstraZeneca Sues FDA Over Generic SEROQUEL Labeling Carve-Out Issue After FDA Issues Non-Response Citizen Petition Denial
- March 19, 2012
- LEGAL ALERTS/ARTICLES
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A Trio of Reports Discuss the Benefits of the Pediatric “Carrot and Stick” Statutes, the Orphan Drug Act, and Hatch-Waxman
- March 14, 2012
- LEGAL ALERTS/ARTICLES
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FDA Cements “It’s Our Party and We’ll Punt if We Want to” Stance on 180-Day Exclusivity Failure to Obtain Tentative Approval Forfeiture Decisions
- March 13, 2012
- LEGAL ALERTS/ARTICLES
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On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
- March 02, 2012
- LEGAL ALERTS/ARTICLES