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The FDA's 'Wish List': A Unified Agenda
By: David Steinberg, Steinberg & Associates
Posted: March 30, 2010, from the April 2010 issue of Cosmetics & Toiletries.
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2. Proposed rule stage: Items listed as being in the “proposed rule stage” on the agenda, including sunscreen products, were expected to be completed by the end of February 2010 based on the last Unified Agenda issued in May 2009. The first action on the agenda addressed products containing the combination of sunscreen and insect repellent ingredients. The second action addressed active ingredients under Time and Extent Application (TEA) review while the third action addressed other efficacy issues for OTC sunscreen drug products. Finally, the fourth action addressed sunscreen formulation, labeling and testing requirements for both UVB and UVA radiation protection.
The timetable for the completion of proposed rules for combined sunscreens and insect repellents is yet to be determined (TBD). Regarding the development of proposed rules for sunscreen efficacy issues on UVA/UVB protection, May 2010 is the expected deadline. In the case of active ingredients under TEA review, no date was given, which could mean the TEAs may be issued at any time.
3. Final rule stage: Five agenda items relevant to personal care fell within the “final rule” stage.
1) External analgesic products: The Final Monograph addresses the 2003 proposed rule on patches, plasters and poultices and the related proposed rule will address issues not addressed in previous rulemakings. The timetable for the final action on external analgesic products—i.e., by which dosage forms are expected to be completed—is September 2010. For proposed rules for other issues regarding these products, the timetable is TBD.
2) Labeling of small-sized OTC drugs: The final action item addressing labeling for convenience or small-sized OTC drug packages is expected to be completed by May 2010.