FDA Targets Acetaminophen Safety Evaluation In Plan To Mine OTC Use Data
This article was originally published in The Pink Sheet Daily
An RFP to provide FDA with direct access to data on consumers’ OTC use identifies the public health impact of potential changes in dosing information on acetaminophen product labels as one reason for the planned data evaluation. Access to the data also will increase FDA’s ability to perform regulatory impact studies, particularly to assess the impact of Rx-to-OTC switches.
You may also be interested in...
In Brief: FDA responds to Nasacort suit, acts on acetaminophen and continues medical food enforcement
FDA responds to Nasacort Allergy suit; FDA will act on lower acetaminophen dose; FDA warns consumers about wart removers; FDA continues medical food enforcement; Supplements must include declared ingredients; CHPA applauds DXM-related legislation; and USP opens Shanghai facility.