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新兽药及新兽药申请的批准;赞助商的变更;新兽药申请批准的撤销(New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications)

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放大字体  缩小字体 2014-12-23 02:22:39  来源:美国联邦公报  浏览次数:848
核心提示:美国FDA正在修订兽药条例以反映2014年9月和10月期间新兽药申请及简式新兽药申请的审批情况。同时,FDA告知公众可于需要时获取审批依据及环境评估文件摘要信息。本次修订内容还包括6份新兽药申请及4份简式新兽药申请赞助商的变更,申请人自愿撤销一份ANADA的申请并更正一处修正案。
发布单位
美国FDA
美国FDA
发布文号 暂无
发布日期 2014-12-15 生效日期 暂无
有效性状态 废止日期 暂无
备注

美国FDA修订兽药条例以反映2014910月期间新兽药申请及简式新兽药申请审批情况。同时FDA告知公众可于需要时获取审批依据及环境评估文件摘要信息本次修订内容还包括6新兽药申请及4份简式新兽药申请赞助商变更申请人自愿撤销一份ANADA申请更正一处修正案。

  ACTION

  Final Rule, Technical Amendment.

  SUMMARY

  The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of six NADAs and four ANADAs, the voluntary withdrawal of approval of an ANADA, and a correcting amendment.

  TABLE OF CONTENTS

  Back to Top

  DATES:

  FOR FURTHER INFORMATION CONTACT:

  SUPPLEMENTARY INFORMATION:

  List of Subjects

  PART 510—NEW ANIMAL DRUGS

  PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

  PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

  PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

  TABLES

  Back to Top

  Table 1—Original and Supplemental NADAs and ANADAs Approved During September and October 2014

  DATES:

  Back to Top

  This rule is effective December 15, 2014, except for the amendment to 21 CFR 520.1660d, which is effective December 26, 2014.Show citation box

  FOR FURTHER INFORMATION CONTACT:

  Back to Top

  George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, george.haibel@fda.hhs.gov.

        全文下载:   Federal Register _ New Animal Drugs; Approval of New Animal Drug Application.pdf
 

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