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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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." The proposed label amendment was requested by FDA in 2005, along with several other changes to OTC NSAID labels (1 (Also see "Requested OTC NSAID Labeling Includes Cardiac Risk, Front Panel Changes" - Pink Sheet, 20 Jun, 2005.), p. 5). Finalization of the rule is slated for May 2007, according to the agenda, which was recently published in the Federal Register (2 'The Tan Sheet' May 1, 2006, In Brief). FDA will push back regulatory action on several other planned rules, including a notice of proposed rulemaking (NPRM) on "oral health care products used to reduce or prevent dental plaque and gingivitis" (see chart: " 3 FDA Semi-Annual Regulatory Agenda Targets "). The NPRM originally was scheduled for October 2006, but has been pushed back to Spring 2007. An NPRM on consumer topical antimicrobial products also has been delayed. The reg previously had been slated for publication in March 2006 along with proposed rules on healthcare antiseptics and topical antimicrobials; however, now it is slated for December release. The Nonprescription Drugs Advisory Committee met in 2005 to discuss safety and efficacy concerns, and recommended that manufacturers of non-alcohol based antiseptics be required to show proof of benefit prior to sale (4 (Also see "Antiseptic Products “Not Effective” In Reducing Skin Infection – FDA" - Pink Sheet, 17 Oct, 2005.), p. 4). Other rulemakings cited in the agenda include an NPRM on the use of the ingredient ipecac in poison treatments, scheduled to appear in May 2007. FDA also expects to finalize action on label warnings for products containing the spermicide nonoxynol-9 in May, with a proposed rule on vaginal contraceptive drugs expected in August. On the supplement side, publication of a final rule concerning dietary supplement Good Manufacturing Practices is slated for December publication. GMPs have been under review by the White House Office of Management & Budget since October 2005; the normal timeframe for OMB review is 90 days. - Melina Vissat |