2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC856
Submitter : Dr. Emily Godfrey Date & Time: 10/13/2005 10:10:52
Organization : Dr. Emily Godfrey
Category : Health Professional
Issue Areas/Comments
Plan B needs to be approved for Over the Counter by all women and girls. It is a matter of health and safety for our society. no evidence supports that girls under age 16 would use the drug irresponsively.