Drugs

PDUFA Formal Meeting Guidance

FDA has published a draft guidance, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, with recommendations on formal meetings relating to the development and review of drug or biological drug products regulated by CDER and CBER. The document does not apply to ANDAs, applications for biosimilar biological products, or submissions for medical devices.

For this guidance, a “formal meeting” is any meeting requested by a sponsor or applicant following the procedures in the guidance, FDA says. It includes meetings conducted in any format.

“This guidance discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings,” the guidance says. “The general principles in this guidance may be extended to other nonapplication-related meetings with external constituents, insofar as this is possible.”

The guidance includes an Introduction, Background, Meeting Types, Meeting Formats, Meeting Requests, Assessing and Responding to Meeting Requests, Meeting Package, Preliminary Responses, Rescheduling and Canceling Meetings, Meeting Conduct, Meeting Minutes, References, and an Appendix.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome