CFR 21-600.81-2014
食品和药物. 第600部分:生物制品:总则. 第D子部分:总则. 第600.81节:分布报告.

Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.81:Distribution reports.


 

 

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标准号
CFR 21-600.81-2014
发布
2014年
发布单位
US-CFR-file
当前最新
CFR 21-600.81-2014
 
 
适用范围
The licensed manufacturer shall submit to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research (see mailing addresses in §600.2), information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. The interval between distribution reports shall be 6 months. Upon written notice, FDA may require that the licensed manufacturer submit distribution reports under this section at times other than every 6 months.

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