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 : EC981
Submitter : Ms. Andrea Irwin Date & Time: 10/27/2005 09:10:31
Organization : Ms. Andrea Irwin
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
The FDA has long been hailed as an independent entity that promotes public health through science and evidence, not ideology and politics. The fact that women have had to wait for more than two years for the FDA to issue a decision on the Plan B application is unacceptable. Please make women?s health the FDA?s first priority by ending this undo delay.