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 : EC796
Submitter : Ms. Judith Byrnes Date & Time: 10/13/2005 08:10:35
Organization : Ms. Judith Byrnes
Category : Health Professional
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
As a registered nurse for 35 years, the influence of politics and religion over matters of health and science is un-American and without merit or conscience!
Emergency contraception should be approved without delay!
Fewer positions in the FDA should be filled by political appointees. They should be filled by persons dedicated to the common good and public health.