Court Opinion

ID: 8609240
Source: CourtListenerOpinion
Date Created: 2022-11-24 06:41:13.491072+00
Date Added: 2024-06-11T16:55:19.183046
License: Public Domain

JUDGMENT

PER CURIAM.
This appeal was considered on the record from the United States District Court for the District of Columbia and on the briefs and arguments by the parties. The Court has determined that the issues presented occasion no need for an opinion. See D.C.Cir. R. 36(b). It is
ORDERED AND ADJUDGED that the judgment of the district court— accompanied by its thoughtful opinion — is affirmed. We add only two points. The first is that the district judge’s opinion, which grants Chevron deference to the FDA’s statutory interpretation of 21 U.S.C. § 355(j)(5)(B)(iv) embodied in FDA approval letters (i.e., informal adjudications), is supported by the Supreme Court’s post-Mead decision in Barnhart v. Walton, 535 U.S. 212, 222, 122 S.Ct. 1265, 152 L.Ed.2d 330 (2002), as well as our own decision in Mylan Laboratories, Inc. v. Thompson, 389 F.3d 1272, 1279-80 (D.C.Cir.2004). Moreover, the FDA’s interpretation of 21 U.S.C. § 355(j)(5)(B)(iv) is clearly supported by its regulation, 21 C.F.R. § 314.107(c)(1), which also warrants Chevron deference under United States v. Mead Corp., 533 U.S. 218, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001).
Pursuant to D.C. Circuit Rule 36, this disposition will not be published. The Clerk is directed to withhold issuance of the mandate herein until seven days after resolution of any timely petition for rehearing or rehearing en banc. See Fed. R.App. P. 41(b); D.C.Cir. Rule 41.