Dear Anon,
To very specifically answer your question about Phase 1/2 clinical study reports: No, the Agency will not have time to review them. We have been told to not even include a full protocol, but only synopses, since there is not enough time to review. For an End of Phase 2 the Agency has 50 days, but for a scientific review of a protocol or clinical study report they would need a lot more time (see appendix tables for some timelines in MAPP 6030: https://www.fda.gov/media/85790/download).
Since the FDA only has limited time to review a meeting package only summaries should be included. At the heart of the meeting package in 1.6.2 are usually the questions (Does the Agency agree with XYZ?) followed by a succinct Sponsor position justifying the rationale. The key data that is mentioned in the supporting position is provided in a Section called "Data to support the discussion" organized by discipline according to the eCTD structure, more or less.
When considering what amount of key data to include in the supporting data section of the package you have a lot of leway. But it should be enough for the FDA to respond to your questions. Otherwise you will get a non answer "we are not able to provide a response because XYZ was not provided". Often the level of detail we provide is similar to what's in the Investigator's Brochure, but may be more detailed or information not yet included in the current Investigator's Brochure. We also often link directly to the Investigator's Brochure for easy access to a more comprehensive look at what is known about the molecule, or to clinical and other study reports already submitted to the IND. That way a reviewer can go deeper if they want more detailed information.
You can also consider appendix tables listing clinical studies or nonclinical studies with key information or findings, since the FDA will be looking to evaluate the following (again, according to the MAPP 6030):
- Phase 3 trial design (including dose selection and endpoint selection)
- Adequacy of safety database
- Pediatric studies, including studies required under PREA and Written Requests issued under the Best Pharmaceuticals for Children Act
- Additional information needed to support NDA/BLA
- Context for SPA submission
- Adequacy of supporting nonclinical data
- Adequacy of supporting clinical pharmacology data
- Adequacy of supporting abuserelated data
- Use of data standards for submission
Also of course look at the updated 2023 guidance on PDUFA meetings.
Good luck!
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Anna Sedello, PhD, RAC-Drugs
Executive Director, Regulatory Affairs
Palo Alto CA
United States
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Original Message:
Sent: 30-Oct-2023 15:17
From: Anonymous Member
Subject: Data required for EOP2 meeting
This message was posted by a user wishing to remain anonymous
Just summaries of studies done so far! This is not a NDA/BLA rather EOP2 briefing package! Questions followed by your rationale.
Original Message:
Sent: 30-Oct-2023 10:41
From: Anonymous Member
Subject: Data required for EOP2 meeting
This message was posted by a user wishing to remain anonymous
Hello,
Would you please describe what is typically expected to be available from the P1 and P2 studies for an EOP2 meeting. For example, do you need final CSR from P2? What else?
Many thanks.