OTC office would be established under House FDA reform legislation.
This article was originally published in The Tan Sheet
Executive Summary
FDA OTC OFFICE WOULD BE ESTABLISHED UNDER HOUSE FDA REFORM BILL introduced March 29 by Rep. Richard Burr (R-NC). The bill, which covers drug and biologics issues, would establish, within the Center for Drug Evaluation and Research, an office with sole responsibility for reviewing and acting upon "all applications or petitions to switch a drug from prescription to over-the-counter status" and "all other matters related to nonprescription drugs."