Geriatric drug labeling

FDA is soliciting public comment on its proposed collection of information on the “Geriatric Use” subsection of labeling for prescription drugs. Information related to the use of the drug by elderly or geriatric patients must be included, where appropriate, in the precautions, indications and usage, dosage and administration, clinical pharmacology or clinical studies, contraindications, and warnings sections.

FDA wants to know if collecting this information is necessary and useful; if it has correctly estimated the burden of collecting this information if there are ways to enhance the quality, utility, and clarity of the information; and if there are ways to minimize the burden of collection. Comments are due by May 10, 2004.

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