Extension Of Deadlines By FDA Was Valid, Deeming Rule Plaintiffs Say

(September 16, 2019, 4:40 PM EDT) -- WASHINGTON, D.C. — In an Aug. 8 amended complaint, plaintiffs challenging the U.S. Food and Drug Administration’s “Deeming Rule” added a new count seeking a declaration that the FDA’s subsequent 2017 Guidance, which extended compliance deadlines for premarket approval applications and substantial equivalence reports, remains “valid and in effect” (Cigar Association of America Inc., et al. v. U.S. Food and Drug Administration, et al., No. 16-1460, D. D.C.)....