21 C.F.R. §12.24 - Ruling on objections and requests for hearing
| Cite as | 21 C.F.R. §12.24 |
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4 cases
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Community Nutrition Institute v. Young, s. 84-1153
...21 U.S.C. Sec. 348(f) (1982). The FDA has promulgated regulations that require the FDA to take a hard look at the objections. See 21 C.F.R. Sec. 12.24(b)(1)-(3). While the FDA's denial of the hearing obviates our need to assess whether the instant case meets the mandamus standard, we could ......
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Pharm. Mfg. Research Servs., Inc. v. Food & Drug Admin.
...... under the governing law." John D. Copanos & Sons, Inc. v. FDA , 854 F.2d 510, 522–23 (D.C. Cir. 1988) (citation omitted); see also 21 C.F.R. § 12.24(b)(4) ("A hearing will not be granted on factual issues that are not determinative with respect to the action requested."). For many of th......
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Tamas v. Safeway, Inc., G050114
...“that the objectors raise a genuine and substantial issue of fact that must be resolved at a public hearing as provided for in 21 CFR 12.24.” (Ibid. )Thus, in accordance with title 21 United States Code section 371(e), the FDA announced it was “staying the effective date of the provisions .......
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Marshall Minerals, Inc. v. Food and Drug Administration
...... ("Marshall"), for a public hearing on its petition, dated August 12, 1977, for a ...(c) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 348(b) and (c). 1 We reverse . ... which provides for a public hearing on objections to an order by any person adversely affected ... See Title 21 CFR 25.1. Specific data supporting safety of gentian ... Marshall specifically requests a hearing on this objection numbered 1. . (2) . ......