US FDA To Offer Bioequivalence Data

The US Food and Drug Administration's Office of Generic Drugs Bioequivalence Division says it will make the review of the first acceptable protocol for a drug publicly available to potential sponsors and contract research organizations, in order to assist them and reduce the number of multiple protocols which it receives.

Products for which no guidances exist, and for which the FDA has yet to receive an acceptable protocol, will eventually be the primary target of this new policy, the division says.