美国FDA 指导原则 根据GDUFA行业指导,FDA和ANDA申请者之间的完成回复函澄清电话会议 英文原版.pdfVIP

  • 1
  • 0
  • 约2.94万字
  • 约 12页
  • 2023-05-22 发布于四川
  • 举报

美国FDA 指导原则 根据GDUFA行业指导,FDA和ANDA申请者之间的完成回复函澄清电话会议 英文原版.pdf

Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2022 Generic Drugs Revision 1 Contains Nonbinding Recommendations Post-Complete Response Letter Clar

您可能关注的文档

文档评论(0)

1亿VIP精品文档

相关文档