21 CFR 130.8 - Conformity to definitions and standards of identity
| Cite as | 21 CFR 130.8 |
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2 practice notes
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U.S. v. Dakota Cheese, Inc., Nos. 89-5132
...definition and standard of identity if it "contains an ingredient for which no provision is made in such definition and standard." 21 C.F.R. Sec. 130.8(a). Thus, we agree with the government that the language of the regulations is clear and that the contract specifications did not permit th......
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USV Pharmaceutical Corporation v. Richardson, No. 71-1596.
...withdraw the approval. As one commentator has accurately summed up, "It is true that a manufacturer may withdraw a pending NDA. Sec. 21 C.F.R. sec. 130.8 (1971). However, no provision in the law permits a manufacturer to withdraw an effective NDA; only the FDA can do so through Section 505(......
2 cases
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U.S. v. Dakota Cheese, Inc., s. 89-5132
...definition and standard of identity if it "contains an ingredient for which no provision is made in such definition and standard." 21 C.F.R. Sec. 130.8(a). Thus, we agree with the government that the language of the regulations is clear and that the contract specifications did not permit th......
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USV Pharmaceutical Corporation v. Richardson, 71-1596.
...withdraw the approval. As one commentator has accurately summed up, "It is true that a manufacturer may withdraw a pending NDA. Sec. 21 C.F.R. sec. 130.8 (1971). However, no provision in the law permits a manufacturer to withdraw an effective NDA; only the FDA can do so through Section 505(......