21 C.F.R. §314.410 - Imports and exports of new drugs
| Cite as | 21 C.F.R. §314.410 |
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4 cases
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Cook v. Food, s. 12–5176
...foreign manufactured drug as an investigational new drug (IND), thereby allowing its lawful importation. 21 U.S.C. § 355(i); 21 C.F.R. § 314.410(a)(1)(ii); see also21 C.F.R. 312.315(a)(3)(ii) (FDA may expand access to an IND “contain [ing] the same active moiety as an approved drug product ......
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Beaty v. Food & Drug Admin., Civil Case No. 11–289(RJL).
...has been submitted and approved by the FDA, or if the drugs comply with the regulations regarding investigational new drugs. 21 C.F.R. § 314.410(a)(1) (2008). Second, no drug may be legally imported unless it is both properly listed with the FDA and comes from a properly registered foreign ......
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Beaty v. Food & Drug Admin., Civil Case No. 11-289 (RJL)
...has been submitted and approved by the FDA, or if the drugs comply with the regulations regarding investigational new drugs. 21 C.F.R. § 314.410(a)(1) (2008). Second, no drug may be legally imported unless it is both properly listed with the FDA and comes from a properly registered foreign ......
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Cook v. Food & Drug Admin., 12-5176
...foreign manufactured drug as an investigational new drug (IND), thereby allowing its lawful importation. 21 U.S.C. § 355(i); 21 C.F.R. § 314.410(a)(1)(ii); see also 21 C.F.R. 312.315(a)(3)(ii) (FDA may expand access to an IND "contain[ing] the same active moiety as an approved drug product ......