In
The Board took over 37 months from institution to issue its FWD. Purdue appealed the Board's decision, arguing that the Board lacked authority to issue a FWD beyond the 18-month deadline after institution to do so. The Federal Circuit evaluated the statute's language, structure, and legislative history and concluded that because §326(a)(11) does not specify any consequences for non-compliance with the 18-month deadline, the Board had authority to issue a FWD after the deadline. This holding was consistent with Supreme Court precedent regarding other statutes without any specified consequences for non-compliance with a deadline. The Federal Circuit cautioned, however, that the Board "may not ignore statutory deadlines" and that the "appropriate remedy is mandamus."
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