Comment from RCSS (Regulatory Consulting & Scientific Solution)
AnonymousOtherIndividual
Summary: Dr. Nathalie Machluf is seeking clarification on specific details regarding the draft guidance, including meeting types for standard products, potential timeline differences for WRO meetings, and the effective date for implementation. The commenter does not express a clear stance of support or opposition to the proposed action.
To whom it may concern,
Thank you for the opportunity to comment/ask questions.
1) Is it correct to understand that for a standard product (not for serious condition), the meeting to request for an end-of-phase I meeting would be a Type C meeting? If this is correct, I think it would be beneficial to be specified in the guidance.
2) The format of the meeting to be chosen by the Sponsor (for instance face-to-face or WRO) would not affect its timelines. If the FDA would like to encourage Sponsors choosing WRO to circumvent the logistic complexity of face to face or virtual meeting, I would think that shorter timelines should be set for WRO versus meetings.
3) The guide specify that it is a draft "not for implementation" but per the register the guide from 2017 is replaced by this one issued in 2023. May you please clarify whether Sponsor can start to use this new guide and request for instance an INTERACT meeting, or Sponsor should still be using the previous guidance.
Thank you very much for your considerations,
Best regards,
Dr. Nathalie Machluf