FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary

FDA recommends that ingestible fluoride drug products – typically available as tablets and drops – should be limited to children aged three years and older who are at high risk for tooth decay.

The Food and Drug Administration is advising consumers not to purchase or use Umovy, a product promoted and sold for joint pain on various websites, including www.umovy-usa.com, and possibly in some retail stores.

Unapproved New Drugs/Misbranded

FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine

FDA releases guidance on how remote interactive evaluations will be requested by FDA and conducted for the duration of COVID-19 at drug facilities.

Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to make labeling changes based on new safety information. Learn more.