Standards for topical active ingredients must allow real world evidence
What the document says“utilize standards that allow for the use of real world evidence (as defined in section 505F(b)), as appropriate, as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredients, to supplement evidence from traditional clinical trials”
The section adds a new subsection (r) to section 505G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h). The standards still have to let the Secretary weigh whether the benefits of an ingredient outweigh its risks.
What the document actually says“utilize standards that allow for the use of real world evidence (as defined in section 505F(b)), as appropriate, as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredients, to supplement evidence from traditional clinical trials”
The agency must use standards that let it count evidence from real use. That evidence adds to what trials show.
Real world evidence comes from ordinary use, not a study. Many of these ingredients have been on sale for years. That record can now count.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.