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Changes in Labeling Statin Drugs – What the New FDA Draft Guidance Says
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On Feb 28 2012, the FDA released new draft guidance on safety changes for widely used cholesterol – lowering or statin drugs. These regulations aim to educate, update health care professionals and patients about the health benefits as well as risks associated with these drugs.

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Contributing Authors/ Experts
Michael Anisfeld, Senior Consultant, Globepharm Consulting Inc.
Sonia Gourary, Senior Compliance Consultant, Quality and Compliance Partners
R. Wayne Frost, President, Frost Biopharmaceutical Consulting
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