CHPA, GSK Advise Against Plan B Rulemaking As 44,000 Comments Pour In
This article was originally published in The Tan Sheet
Executive Summary
"Sufficient precedent" exists to allow even "narrow distinctions" to differentiate Rx and OTC versions of a dual-status drug and FDA does not need to initiate a rulemaking on the matter, the Consumer Healthcare Products Association maintains
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Plan B comment analysis is being handled by an outside contractor with oversight by FDA's Office of Policy, according to Acting Commissioner Andrew von Eschenbach, MD