21 CFR 514.8 - Supplements and other changes to an approved application
| Cite as | 21 CFR 514.8 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
35 practice notes
-
Lindquist v. Tambrands, Inc., Civ. No. 4-88-443.
...changes are required to be made, in other contexts the FDA has required the changes to be made at the "earliest possible time." See 21 C.F.R. § 514.8(d) (concerning drugs for use in In 1982, in response to the discovered association between TSS and tampon use, the FDA adopted labeling requi......
-
Osburn v. Anchor Laboratories, Inc., No. 86-1094
...the regulations required Rachelle to submit a proposed label of its own choosing, which the FDA would then approve or reject. See 21 C.F.R. Part 514 (New Animal Drug Applications); id. Sec. 514.2(b)(3)(iii). Of special significance is the fact that the FDA regulations specifically permitted......
-
Statins and Adverse Cardiovascular Events in Moderate‐Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims
...FDA approval, but after FDA notification (§§ 314.70(c) and601.12(f)(2)).FDA, supra note 15, at 3934, 2006 WL 160271. See 21 C.F.R. §§ 314.70, 514.8, 601.12; 72 Fed.Reg. 73589–73602, 2007 WL 4555142.101Consumer-Directed Promotion of Regulated Medical Products; Public Hearing, 70 Fed. Reg.5405......
-
Schedules of Controlled Substances: Placement of Alfaxalone into Schedule IV
...law restricts this drug to use by or on the order of a licensed veterinarian (i.e., it may only be administered). 21 CFR 522.52; see also 21 CFR 514.8. Scheduling Based on consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS, and ba......
Request a trial to view additional results
5 cases
-
Lindquist v. Tambrands, Inc., Civ. No. 4-88-443.
...changes are required to be made, in other contexts the FDA has required the changes to be made at the "earliest possible time." See 21 C.F.R. § 514.8(d) (concerning drugs for use in In 1982, in response to the discovered association between TSS and tampon use, the FDA adopted labeling requi......
-
Osburn v. Anchor Laboratories, Inc., No. 86-1094
...the regulations required Rachelle to submit a proposed label of its own choosing, which the FDA would then approve or reject. See 21 C.F.R. Part 514 (New Animal Drug Applications); id. Sec. 514.2(b)(3)(iii). Of special significance is the fact that the FDA regulations specifically permitted......
-
American Cyanamid Co. v. Food and Drug Administration, No. 77-1969
...v. FCC, 189 U.S.App.D.C. 139, 149-150, 581 F.2d 917, 927-928 (1978). 17 Brief for Petitioner at 12; Brief for Respondents at 5. 18 21 C.F.R. § 514.8 (1978) does, however, recognize supplemental NADAs and requires certain proposed changes to be supported in specified ways. It does not in ter......
-
Rhodia, Inc., Hess & Clark Division v. Food and Drug Administration, No. 77-1616
...method of manufacture, and changes in commercial batch size, are permitted without the submission or approval of a supplemental NADA. 21 C.F.R. § 514.8(a)(5)(iii), (iv) (1978). An applicant may add new distributors of an approved drug automatically upon submission of a supplemental NADA for......
Request a trial to view additional results
1 books & journal articles
-
Statins and Adverse Cardiovascular Events in Moderate‐Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims
...FDA approval, but after FDA notification (§§ 314.70(c) and601.12(f)(2)).FDA, supra note 15, at 3934, 2006 WL 160271. See 21 C.F.R. §§ 314.70, 514.8, 601.12; 72 Fed.Reg. 73589–73602, 2007 WL 4555142.101Consumer-Directed Promotion of Regulated Medical Products; Public Hearing, 70 Fed. Reg.5405......