FDA semi-annual agenda
This article was originally published in The Rose Sheet
Executive Summary
Notice of proposed rulemaking for OTC UVA/UVB sunscreens is expected to be released this month, according to FDA's semi-annual agenda, published in an April 24 Federal Register 1notice. Agency anticipated a December 2005 release date for the rule in its last semi-annual agenda (2"The Rose Sheet" Nov. 7, 2005, In Brief). FDA partially stayed the OTC final sunscreen monograph in 2002 to develop UVA/UVB guidelines. Additional items on the semi-annual agenda include releasing NPRM for skin bleaching products this month and NPRM for OTC topical antimicrobial drug products in December. Final action on OTC dandruff, seborrheic dermatitis and psoriasis products is slated for August, and FDA aims to issue technical amendments to the final action on skin protectant products in June...