Jan. 1 at 7:13 AM
$BCLI
Paragraph 2 Long answer and, more fundamentally, the Administrative Procedure Act imposes a binding duty. Under 5 U.S.C. § 555(b), “With due regard for the…necessity of the parties…and within a reasonable time, each agency shall proceed to conclude a matter presented to it.” This creates an unambiguous obligation for the FDA to resolve citizen petitions, including by issuing a final decision after a tentative response, without undue delay. Additionally, under 5 U.S.C. § 706(1), courts “shall…compel agency action unlawfully withheld or unreasonably delayed,” providing a judicial lever if the FDA fails to act in a reasonable timeframe.