FDA Posts Draft Guidance on Child-Resistant Packaging Statements in Drug Labeling
The Food and Drug Administration on Aug. 2 posted a new draft guidance document on child-resistant packaging statements in drug labeling, it said in a notice. The document is “intended to assist applicants, manufacturers, packagers, and distributors who choose to…
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include child-resistant packaging (CRP) statements in prescription and over-the-counter human drug product labeling,” FDA said. Topics covered include what information that should be included to support statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements to these applications, FDA said. Comments are due Oct. 2.