FDA floats new nonprescription drug labeling options . . .

Gottlieb: Draft Guide Will Expand Nonprescription Drug Space, Lower Cost

By Beth Wang / July 19, 2018 at 8:25 PM
FDA, in a bid to expand use of nonprescription drugs, issued a draft guidance Tuesday (July 17) that proposes two new ways sponsors could demonstrate the safety and effectiveness of nonprescription drugs: providing supplemental information about a drug beyond what is included on the drug facts label (DFL) and requiring consumers meet certain criteria before being allowed to purchase the product. Increasing consumers' access to nonprescription drug products will help lower health care costs, FDA Commissioner Scott Gottlieb said. Currently,...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.