FDA-Initiated OTC Switches Could Be Based On Foreign Data – McClellan
This article was originally published in The Tan Sheet
Executive Summary
FDA may rely on a drug's foreign OTC marketing experience to determine whether an Rx product should be switched OTC in the U.S. without sponsor consent, Commissioner Mark McClellan, MD/PhD, said at a Manhattan Institute roundtable discussion for buyside analysts May 16
You may also be interested in...
OTC Labeling Adopted By FDA In Forced Switch Would Violate Regs Comments Say
FDA could not adopt a drug's approved OTC label from another country as acceptable U.S. OTC labeling without violating its own regulations, according to the American Association of Physicians & Surgeons and Competitive Enterprise Institute
Behind-The-Counter Drug Class “On The Table” At CHPA
The Consumer Healthcare Products Association appears to have softened its steadfast opposition to a possible behind-the-counter third class of drugs
FDA Cautious On Forced Rx-To-OTC Switches
While FDA has concluded internally it has the authority to determine whether a drug should be Rx or OTC, the agency is being cautious about an official announcement of its position