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Final Guidance Gives Direction on Dosing Section of Labeling

March 31, 2010
A final guidance for industry clarifies what the FDA expects from drugmakers in the dosage and administration section of drug and biologic labeling and helps implement a 2006 regulation to make product labels easier for healthcare practitioners to read and use. The guidance is one in a series detailing FDA requirements for content and format of labeling for new and recently approved drug and biologic products, bringing agency documents in line with 21 CFR 201.57(c)(3).
Washington Drug Letter