BioCentury
ARTICLE | Clinical News

U.S. Food and Drug Administration (FDA) regulatory update

March 5, 2012 8:00 AM UTC

FDA will hold a public hearing on March 22-23 to discuss a potential pathway for OTC approval of products that would otherwise be available only by prescription. FDA is seeking comments on what types of evidence would be needed to show that certain drugs could be used safely in the OTC setting and which medical conditions or diseases would benefit from OTC availability. Comments on the notice are due March 9. ...