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Regulatory Update

Posted 01 May 2009 | By

Draft Guidance for Industry on the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format (Docket No. FDA-2009-D-0095) FDA announced the availability of this draft guidance in the Federal Register, 3 March 2009. This is one of a series of guidance documents intended to assist applicants in complying with new FDA regulations designed to make information in prescription drug labeling easier for healthcare practitioners to access, read and use. In particular, this guidance addresses the requirement that the clinical pharmacology section of the labeling contain information on mechanism of action, pharmacodynamics and pharmacokinetics. Comments may be submitted in writing to the Division of Dockets Management (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD 20852 or filed electronically. Comments must be submitted no later than 1 June 2009.

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