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Headlines

Perampanel proposed as Schedule III controlled substance


The Drug Enforcement Administration (DEA) is proposing to place the substance perampanel [2-(2-oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile hydrate], including its salts, isomers, and salts of isomers, into Schedule III of the Controlled Substances Act (CSA).

If finalized, this Proposed rule would impose regulatory controls and administrative, civil, and criminal sanctions of Schedule III controlled substances on individuals who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, and possess) or even propose to handle perampanel. This Proposed rule is based on a recommendation from the Assistant Secretary for HHS and on an evaluation of all other relevant data by the DEA. Comments on the proposal should be submitted no later than November 21, 2013. FDA Proposal, ¶46,211

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FDA proposes changes for annual report on data collected from sponsors of antimicrobial new animal drugs


The FDA has issued a proposed rule regarding the content and format of data tables for its annual summary report of sales and distribution data collected from sponsors of antimicrobial new animal drugs, in accordance with the new animal drug records and reporting provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). Comments on the proposed rule are due November 23, 2013. FDA Proposal, ¶46,210

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FDA request to delay issuance of proposed food safety regulations refused


The FDA is required submit a notice of proposed rulemaking (NPRM) regarding intentional adulteration rules by the court-ordered November 30, 2013 deadline. Although the FDA requested a stay pending the appeal of the court’s order, there was no reason to grant it, because the court determined that submitting the NPRM was unlikely to cause irreparable harm to the FDA. Center for Food Safety v Hamburg, N.D. Cal., ¶39,462

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State failure to warn claims against generic drug manufacturer preempted


Pro se products liability claims brought against a generic drug manufacturer based on a failure-to-warn theory were preempted by federal law. Because the generic drug manufacturer was required to use the same FDA approved labeling as the brand manufacturer, and could not legally change the labeling even to add additional warnings, the state law claims alleging that the labeling was inadequate would conflict with FDA regulations and were therefore preempted. Ko v Mutual Pharmaceutical Company, Inc., N.D. Cal., ¶39,461

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