FDA Agenda Slates Stevens-Johnson Proposal For June; GMPs In December?
This article was originally published in The Tan Sheet
Executive Summary
FDA intends to issue a proposed rule to add a warning about Stevens-Johnson Syndrome to the NSAID allergy label in June, the agency announces in HHS' semi-annual "unified agenda.
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HHS unified agenda
FDA will begin reviewing nutrient content "high potency" and "antioxidant" claims this month and plans to complete the work in September 2007, according to the Health & Human Services Department's semi-annual "unified agenda" published in the Dec. 11 Federal Register. FDA also plans to publish a final rule on claims antihistamines can make for the common cold in June 2007, according to the unified agenda. The agency will announce a notice of proposed rulemaking in October 2007 to add Stevens-Johnson warnings on OTC analgesics. It intended to issue the proposed rule in June 2006, according to the previous unified agenda (1"The Tan Sheet" May 15, 2006, p. 8). FDA plans to issue an NPRM in May to "address oral healthcare products used to reduce or prevent dental plaque or gingivitis," the agenda says...
HHS unified agenda
FDA will begin reviewing nutrient content "high potency" and "antioxidant" claims this month and plans to complete the work in September 2007, according to the Health & Human Services Department's semi-annual "unified agenda" published in the Dec. 11 Federal Register. FDA also plans to publish a final rule on claims antihistamines can make for the common cold in June 2007, according to the unified agenda. The agency will announce a notice of proposed rulemaking in October 2007 to add Stevens-Johnson warnings on OTC analgesics. It intended to issue the proposed rule in June 2006, according to the previous unified agenda (1"The Tan Sheet" May 15, 2006, p. 8). FDA plans to issue an NPRM in May to "address oral healthcare products used to reduce or prevent dental plaque or gingivitis," the agenda says...
HHS unified agenda
FDA will begin reviewing nutrient content "high potency" and "antioxidant" claims this month and plans to complete the work in September 2007, according to the Health & Human Services Department's semi-annual "unified agenda" published in the Dec. 11 Federal Register. FDA also plans to publish a final rule on claims antihistamines can make for the common cold in June 2007, according to the unified agenda. The agency will announce a notice of proposed rulemaking in October 2007 to add Stevens-Johnson warnings on OTC analgesics. It intended to issue the proposed rule in June 2006, according to the previous unified agenda (1"The Tan Sheet" May 15, 2006, p. 8). FDA plans to issue an NPRM in May to "address oral healthcare products used to reduce or prevent dental plaque or gingivitis," the agenda says...