US FDA issues CMC draft rules for new NDAs & ANDAs, seeks comments from industry before Sept 23
US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) has issued a draft guidance on chemistry, manufacturing and controls (CMC) which calls for post approval manufacturing changes to drug applicants on the types of changes that are to be included in annual submissions.

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This supplement provides a compact and concise compendium of all of the Federal Rules of Civil Procedure currently in effect, as well as the restyled version of the rules that took effect in December 2007. It also includes the U.S. Constitution and key provisions of title 28 of the United States Code. The supplement’s small size and text limited to the body of rules and statutes make it a convenient resource for students in civil procedure and complex litigation courses needing quick and easy access to relevant statutory provisions during class or for their studies or exams.

Federal Civil Rules Supplement, 2009-2010

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