Opinion ID: 361157
Heading Depth: 2
Heading Rank: 2

Heading: Proceedings Before FDA

Text: 7 On August 30, 1974, FDA published in the Federal Register a notice proposing to withdraw approval of NADA 65-381. 4 39 Fed.Reg. 31678 (1974). The notice stated there were insufficient data to demonstrate that the ingredients of NADA 65-381 were effective in accordance with the requirements for fixed combination drugs as set forth in 21 C.F.R. § 514.1(b)(8)(v) (1977). 5 Masti-Kure thereupon requested a hearing and submitted data purporting to demonstrate the efficacy of the drug covered by NADA 65-381. Joint Appendix (J.A.) at 160. On March 5, 1975, FDA served upon Masti-Kure a proposed order analyzing Masti-Kure's submission and concluding that summary judgment should be instituted since the data submitted failed on its face to meet regulatory standards. J.A. at 684. Masti-Kure was given sixty days to respond with sufficient data, information, and analyses to demonstrate that there is a genuine and substantial issue of fact which justifies a hearing. Id. Masti-Kure responded on May 9 with a revised evidentiary submission. FDA concluded, however, that the deficiencies in the data were unremedied, and, on February 17, 1976, issued its final order withdrawing approval of NADA 65-381 and denying Masti-Kure's request for a hearing. 41 Fed.Reg. 7141 (1976).