FDA Extends Comment Period on Sunscreen Dosage Forms
The Food and Drug Administration has extended the comment period on its June 2011 advance notice of proposed rulemaking (ANPR) requesting data and information on certain dosage forms of over-the-counter (OTC) sunscreen drug products marketed without approved applications. FDA requested the data to establish OTC monograph conditions, including dosage form specifications, for OTC sunscreen drug products in order to help resolve specific questions about the effectiveness and safety of OTC sunscreens in spray dosage forms.
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Comments are now due by October 17, 2011 (from September 15).
(See ITT's Online Archives or 06/09/11 news, 11060952 for BP summary of FDA submitting the ANPR to the Office of Management and Budget.)