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§71.4 着色剂样品及其它资?Samples; additional information)

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放大字体缩小字体2011-09-01 10:13:28 来源:FDA 浏览次数9span id="hits">2504
核心提示:主要介绍了关于着色剂样品以及相关资料的提交。受理专员需要申请人提供着色剂的样本以及着色剂的相关信息文件,信息或样品要求需在呈请书提交?80天内提交,否则申请书将被认定为撤销、/div>
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备注 主要介绍了关于着色剂样品以及相关资料的提交。受理专员需要申请人提供着色剂的样本以及着色剂的相关信息文件,信息或样品要求需在呈请书提交?80天内提交,否则申请书将被认定为撤销、/td>

   更多关于着色剂使用申请的法规,请详?a href="//www.sqrdapp.com/law/dongtai/173325.html">美国FDA 21 CFR ?1部分关于着色剂使用申请的法规汇怺/a>、br />
   71.4 Samples; additional information.

  The Commissioner may request samples of the color additive, articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, and any additional information needed to clarify a submitted method or other aspect of a petition at any time while a petition is under consideration. The Commissioner shall specify in the request for a sample of the color additive, or articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, a quantity deemed adequate to permit tests of analytical methods to determine quantities of the color additive present in products for which it is intended to be used or adequate for any study or investigation reasonably required with respect to the safety of the color additive or the physical or technical effect it produces. The date used for computing the 90-day limit for the purposes of section 721(d)(1 of the act shall be moved forward 1 day for each day, after mailing date of the request, taken by the petitioner to submit the information and/or sample. If the information or sample is requested a reasonable time in advance of the 180 days, but is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice.

地区9/font>美国
标签9/font>认定着色剂
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