In re Doran

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• concluding that the FDA “did not reject Avail’s application because it failed to include certain long-term studies, but rather due to a lack of any ‘valid scientific evidence’ substantial enough to outweigh the known risks to youth of flavored products”
• recognizing the “FDA’s broad statutory mandate to determine from the totality of the evidence”
• reasoning that “internal documents [are] 11 unlikely to create reliance interests” and the July 2021 Memorandum was 12 “rescinded . . . or superseded” by the time the FDA issued its MDO
• reasoning that the memoranda were “internal documents unlikely to create reliance interests”
• explaining that “Avail failed to include” “the type and quality of evidence” the FDA required, and “this failure, rather than the absence of certain [long-term] studies in its PMTAs, resulted in FDA issuing a marketing denial order”
• rejecting a similar challenge based on the FDA’s conclusion that the risks of flavoring were consistent between open and closed systems

Source: CourtListener parenthetical corpus (CC0).