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.
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.
Apr 30, 2004
Machinery Basics
Coding, Marking, and Labeling Innovations Report
Explore our editor-curated report featuring cutting-edge coding, labeling, and RFID innovations from PACK EXPO 2024. Discover high-speed digital printing, sustainable label materials, automated labeling systems, and advanced traceability solutions that are transforming packaging operations across industries.
Access Report
Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More