2(b) or Not 2(b): FDA Releases New Guidance on Determining Whether to Submit an ANDA or 505(b)(2)

“Whether ‘tis nobler to deviate from the RLD and rely on established data, or take arms against a sea of troubles with a bioequivalent product that conforms to the sameness requirement — that is the question.” That might have been Shakespeare’s opening to Hamlet, had the Bard traded quills for regulatory submissions and Denmark for the District of Delaware or New Jersey.... By: ArentFox Schiff