Search Results for:
Kurt R Karst
(277)
- Page 4
ARTICLES(277)
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Bayer Joins the Combo Drug NCE Challenge Club; Petitions FDA for 5-Year Exclusivity for NATAZIA
- May 31, 2013
- LEGAL ALERTS/ARTICLES
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FDA is Asked to Deviate From ANDA “Exception Excipient” Policy for Generic VFEND Injection; Precedent Indicates Agency Will Remain Firm
- May 23, 2013
- LEGAL ALERTS/ARTICLES
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While We’re Waiting on Bartlett, Some New Preemption Challenges to Consider
- May 21, 2013
- LEGAL ALERTS/ARTICLES
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FDA Determines Original OPANA ER Not Discontinued for Safety Reasons; Decision Affirms Case-by-Case Review
- May 16, 2013
- LEGAL ALERTS/ARTICLES
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Generic and Innovator Drugs: The Next Generation
- May 08, 2013
- LEGAL ALERTS/ARTICLES
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False Friends: FDA’s “Gift” on NESINA - Present or Poison? It May Depend on Which Hatch-Waxman Language is Spoken
- May 06, 2013
- LEGAL ALERTS/ARTICLES
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DC Circuit Rules for FDA in SEROQUEL Exclusivity Case; AstraZeneca Not Entitled to 3-Year Exclusivity
- April 30, 2013
- LEGAL ALERTS/ARTICLES
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“Opioid Spring” Blossoms: FDA Finds “Original” OXYCONTIN Discontinued for Safety or Effectiveness Reasons; Will Not Accept or Approve ANDAs
- April 18, 2013
- LEGAL ALERTS/ARTICLES
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Generic BAYTRIL Approval Suspended; Bayer Alleges ANADA Approval Violates GADPTRA and APA
- April 15, 2013
- LEGAL ALERTS/ARTICLES
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D.C. Circuit Decision May Force FDA and Other Agencies to Expedite Responses to FOIA Requests
- April 11, 2013
- LEGAL ALERTS/ARTICLES
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Discord Among Accord and Acorda Over AMPYRA Biostudy Sample Leads to Restricted Distribution Antitrust Lawsuit
- April 03, 2013
- LEGAL ALERTS/ARTICLES
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Timing is Everything! . . . In Life and In Hatch-Waxman; Fun With 180-Day Exclusivity Forfeiture
- April 02, 2013
- LEGAL ALERTS/ARTICLES
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The Big Day Approaches: Supreme Court to Hear Oral Argument in ANDROGEL Drug Patent Settlement Agreement Case
- March 27, 2013
- LEGAL ALERTS/ARTICLES
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Second Circuit Comes to a Split Decision on Standing in NRDC Lawsuit Over OTC Triclosan and Triclocarban Products
- March 22, 2013
- LEGAL ALERTS/ARTICLES
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Preemption, Preemption, and More Preemption - A Cert Petition, a Circuit Court Decision, and the Upcoming Battle in Mutual v. Bartlett
- March 19, 2013
- LEGAL ALERTS/ARTICLES
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KV Says “Heckler/Chaney Defense” is Inapplicable in Appeal Concerning Compounded 17P and Orphan Drug MAKENA
- March 15, 2013
- LEGAL ALERTS/ARTICLES
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FTC Chimes In On Restricted Distribution and Generic Competition; Files Amicus Brief in TRACLEER Case
- March 13, 2013
- LEGAL ALERTS/ARTICLES
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Will New Recommendations From NIH Curb Use of the Animal Efficacy Rule?
- February 21, 2013
- LEGAL ALERTS/ARTICLES
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A New Wrinkle in Generic ACTOS 180-Day Exclusivity; What Might it Mean for Post-MMA Exclusivity?
- February 13, 2013
- LEGAL ALERTS/ARTICLES
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Function Over Form or Form Over Function? Two Petitions Challenge FDA’s NCE Exclusivity Approach for Combination Drugs
- February 12, 2013
- LEGAL ALERTS/ARTICLES
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From the Bleacher Seats: Amici Weigh in for the FTC in ANDROGEL Drug Patent Settlement Agreement Supreme Court Case
- February 07, 2013
- LEGAL ALERTS/ARTICLES
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Insanity? A Nearly Unchanged Preserve Access to Affordable Generics Act is Introduced in Congress
- February 07, 2013
- LEGAL ALERTS/ARTICLES
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Reissue Patents and FDA’s Hidden Policy on 180-Day Exclusivity: A Vestigial Remnant or More?
- February 05, 2013
- LEGAL ALERTS/ARTICLES
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Actelion Seeks Judgment on the Pleadings in Lawsuit Over Restricted Distribution and Biostudy Product Availability
- January 28, 2013
- LEGAL ALERTS/ARTICLES
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Biosimilar Substitution: Battles are Brewing at the State Level
- January 28, 2013
- LEGAL ALERTS/ARTICLES