Last September, we blogged about FDA’s release of Complete Response Letters (“CRLs”) for unapproved NDAs and BLAs, which since then have continued at a steady clip. We observed that the policy marked a significant change from FDA’s longstanding position that such CRLs were exempt from …
Here’s a puzzle: You can sue FDA to challenge a decision on a Citizen Petition, because it is final agency action. See 21 C.F.R. § 10.45(d). Courts have held that you ordinarily cannot sue FDA to challenge Warning Letters, because they generally do not rise to the …
Monday was an eventful day for the parties and practitioners alike who are closely following the ongoing legal challenges to FDA’s attempt to impose civil penalties on businesses alleged to be selling unauthorized e-liquid tobacco products. The day included oral arguments at the Fifth Circuit …
A few months ago, we blogged about a Texas U.S. District Court’s Wulferic ruling that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional under the Seventh Amendment and SEC v. Jarkesy, 603 U.S. 109 (2024). Wulferic, LLC …
FDA’s recent release of 89 Complete Response Letters (“CRLs”) for pending or withdrawn applications (which we blogged about here), and its promise to continue to do so in “real-time” going forward (here), has marked a significant change in FDA policy. Before that, the agency generally …
Late last week, the U.S. District Court for the Northern District of Texas ruled that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional. Relying on the Supreme Court’s recent decision in SEC v. Jarkesy, 603 U.S. 109 …
