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 : EC1941
Submitter : Dr. Michael Brent Date & Time: 10/31/2005 04:10:42
Organization : Dr. Michael Brent
Category : Individual Consumer
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?
No
GENERAL
GENERAL
I do not believe "rule making" is necessary in this case. I believe FDA should follow standard scientific procedures and recommendations without initiating extra, time-consuming processes.