EWG pushes anew for final sunscreen monograph
This article was originally published in The Tan Sheet
Executive SummaryFDA before summer should issue enforceable sunscreen standards that include requirements for ultraviolet-A protection, the Environmental Working Group says. In an April 2 letter to FDA's Center for Drug Evaluation and Research Director Janet Woodcock, EWG 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 European Union, only 17 are approved in the U.S. FDA has said it is aiming to release the final OTC sunscreen monograph in May (1"The Tan Sheet" March 1, 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...
US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca choose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.