EWG pushing again for final sunscreen monograph
This article was originally published in The Rose Sheet
Executive Summary
FDA should make haste - before summer - to issue enforceable sunscreen standards that include requirements for ultraviolet-A (UVA) protection, according to April 2 letter from the Environmental Working Group. Addressed to FDA's Center for Drug Evaluation and Research Director Janet Woodcock, the letter encourages the agency to complete its health and safety reviews of new active ingredients awaiting approval so that sunscreen formulators in the U.S. can move forward with "safer" sunscreens. EWG cites the fact that while 29 ultraviolet filters have been approved in the EU, only 17 have gotten the nod in the U.S. FDA has said it is aiming to release the final OTC sunscreen monograph in May (1"The Rose Sheet" March 22, 2010). An amended final version of the rule was released in 2007, but has been met with criticism from industry
You may also be interested in...
With Summer In Sight, FDA Pushes Final Sunscreen Rule To Fall
FDA aims to issue a final OTC monograph for sunscreens in October, according to the Department of Health and Human Services' semi-annual regulatory agenda published April 26
FDA re-targets final sunscreen rule for May
According to Department of Health and Human Services' Dec. 7 semi-annual agenda, FDA aims to publish a final monograph for OTC sunscreen products in May. The agency has missed its target before, shooting for September in its summer 2009 agenda (1"The Rose Sheet" June 1, 2009). The final version of the monograph - which would address requirements for UVA protection - initially emerged in 1999 but has been consistently delayed. "FDA believes it is important to public health that we issue a final rule for OTC sunscreens as soon as possible," an FDA spokeswoman wrote in a March 17 e-mail to "The Rose Sheet." The agency is likely to take fire if another summer passes without formal protection standards for sunscreen manufacturers (2"The Rose Sheet" Nov. 24, 2008, In Brief)
Scrip M&A Podcast: Which Companies Could Be Acquired Next?
The editorial team from Scrip discusses the M&A potential of various emerging biopharmas, such as Viking, Verona, Altimmune, Xenon and Crinetics.