GUIDANCE DOCUMENT
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products September 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2017-D-6530
- Docket Number:
- FDA-2017-D-6530
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter referred to as products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance does not apply to abbreviated new drug applications, applications for biosimilar biological products, or submissions for medical devices. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant (hereafter referred to as requester(s)) following the procedures provided in this guidance and includes meetings conducted in any format (i.e., in person face-to-face, virtual face-to-face (video conference), teleconference, and written response only (WRO) see in section IV, Meeting Formats).