Panel pressures FDA for final sunscreen monograph
This article was originally published in The Rose Sheet
A panel organized by the Citizens for Sun Protection calls for FDA to finalize the long-awaited sunscreen monograph, require sunscreens to provide both UVA and UVB protection and transparent labeling, and approve photostable, broad-spectrum sunscreen ingredients that defend against UVA and UVB rays, before another summer passes, according to Nov. 20 release. FDA issued in August 2007 a proposed rule to amend the OTC Sunscreen Drug Product Monograph by adding a UVA label standard. The rule is stalled in part because the industry views some labeling requirements as unduly burdensome (1"The Rose Sheet" Jan. 14, 2008, p. 3)
You may also be interested in...
Sunscreen labeling that claims the product "helps prevent" premature skin aging, cancer and other damage does not suggest that sunscreen alone protects against these conditions, but in fact informs consumers that "complementary measures" are needed for adequate protection, trade groups say
Formycon’s CEO has offered the latest indication that the coronavirus outbreak could provide a tailwind for biosimilars, as the firm gave an update on its biosimilars pipeline – including ranibizumab, ustekinumab, aflibercept and an undisclosed molecule, as well as other unrevealed projects – and how it has been affected by the pandemic.
With the formal, virtual kick-off meeting set for 23 July, US FDA and sponsors are looking at a transformed landscape as they discuss what the next five years of user fees will look like.