RAAS Nutritionals tells FDA “it proceeded without an IND because it believed that if it was legally able to sell its nutritional supplements ... it should be able to test and observe the effects of those supplements without an IND.”

Agency safety communication says needle-free dermal filler “pens” sold OTC on social media could pose a serious risk to consumers. It's aware of serious injuries, including  permanent harm to skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers.

A published article from AESGP argues for the increased acceptability, application and use of real-world evidence in the OTC sector where it “may present a more intuitive or efficient way of generating data” compared to randomized controlled trials.

Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.

Authorization was a long time coming for FDA to reform OTC monograph program and streamline process to change formulations, indications or labeling for large majority of drugs available nonprescription. As program is overhauled, monograph updates may seem to be coming just as slowly.

At NAD conference, Commissioner Slaughter identified “erroneous points of conventional wisdom that tend to undergird legal and policy debate about digital surveillance,” starting with privacy being “the key issue” and including “the FTC is toothless, absent new federal legislation.”