Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants Guidance for Industry Formal Meetings Between the FDA and Sponsors or ApplicantsServices, HumanFDA. Guidance for industry formal meetings between the FDA and sponsors or appli- cants. 2009....
FDA review staff and requesters adhere to the meeting management goals that were established under reauthorizations of the Prescription Drug User Fee Act (PDUFA). They are described individually throughout this guidance and summarized ...
FDA review staff and requesters adhere to the meeting management goals that were established under reauthorizations of the Preion Drug User Fee Act (PDUFA). They are described individually throughout this guidance and summarized in the Appendix. This chapter provides recommendations to industry on for...
Because these meetings can often represent critical points in the regulatory and development process, it is important that there are efficient, consistent procedures for the timely and effective conduct of such meetings. Therefore, the guidance also discusses the principles of good ...
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 1 This guidance has been prepared by the Office of New Drugs Meeting Management Process Improvement Team, ...
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 1 This guidance has been prepared by the Office of New Drugs Meeting Management Process Improvement Team, ...
According to the FDA’s guidance, before seeking a meeting, requesters should use the extensive sources of product development information that are publically available. To disseminate a broad range of information in a manner that can be easily and rapidly accessed by interested parties, the FDA ...
Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and ApplicantsGlenn EngelmannMichael W. Ryan
请求信(Meeting requests )可写明适当的审查部门或办公室(如以前被指定),涉及的申请(例如,研究性新药申请(IND)、新药申请(NDA)、生物制品许可证申请(BLA))。通过传真或电子邮件发送的会议请求仅被视为礼节性抄送副本,不能替代正式提交的文件。 会议请求应包括足够的信息,以便FDA评估会议后带来潜在效用,并确定讨论...
FDA Releases Guidance on Formal Disputes