Tag Archives: Active

CDER Exclusivity Board: Can 3-Year Exclusivity Applied to a Prodrug Block 505(b)(2) NDA Approval for the Active Metabolite?

By Kurt R. Karst — This is the second post in a series of posts dedicated to delving into and discussing various issues that arise with both 5-year New Chemical Entity (“NCE”) exclusivity and 3-year new clinical investigation exclusivity based … Continue reading

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Case Law Development: Burden of Proof of Indian Child Welfare Act Element of “Active Efforts” to Reu

The Nebraska Supreme Court joins those states that interpret the Indian Child Welfare Act to require only clear and convincing proof that “active efforts have been made to provide remedial services and rehabilitative programs” 25 U.S.C. 1912(d) in order to… … Continue reading

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States Continue to Chip Away at Donor Anonymity for Politically Active Nonprofits (Missouri and Washington)

With the nonprofit created by now former Governor Eric Greitens very much in the news, the Missouri Ethics Commission (MEC) issued an advisory opinion clarifying that nonprofits are considered "committees" and so subject to registration and public reporting of donor… … Continue reading

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Active Shooter Training

The criminal actions that cause harm to innocent victims can be hard to understand. Joint active shooter training was done with Waltham Police Department, Bentley and Brandeis Police Department, Waltham Fire, and Cataldo and E911 Dispatch. This happened on May … Continue reading

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SC: List of Active Cases Pending Discretionary Review through April 18, 2018

  DISCRETIONARY REVIEW GRANTED 4/18/18  Hayes v. D.C.I. Properties-D KY, 2017-SC-340-DG  Torts. Personal Injury. Trespasser. Attractive Nuisance. Issues include whether the 16-year-old plaintiff can recover for injuries sustained when he trespassed on the defendant’s construction site.  Bryant v. Louisville Metro … Continue reading

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