--- title: "Things to be aware of before continuing" slug: "things-to-be-aware-of-before-continuing" updated: 2025-05-12T23:17:50Z published: 2025-05-12T23:17:50Z canonical: "bgtcplaybook.document360.io/things-to-be-aware-of-before-continuing" --- > ## Documentation Index > Fetch the complete documentation index at: https://bgtcplaybook.document360.io/llms.txt > Use this file to discover all available pages before exploring further. # Things to be aware of before continuing Not all product development programs qualify for an INTERACT meeting – in fact, as mentioned before, a majority of these meetings are denied mostly due to stage of development. You should be able to avoid this using our [readiness assessment checklist](/v1/docs/am-i-ready-for-an-interact-meeting) in the previous section.

The stage of your product development program may be premature if: [1]

 - You do specify the investigational clinical product - You do not provide pre-clinical proof-of-concept or other pilot data - You have not conducted any pre-clinical studies proof-of-concept studies with your asset On the other hand, a request may be **too advanced** for an INTERACT meeting and more appropriate for a Pre-IND meeting if: [[1]](/v1/docs/ref-interact-meeting) - You have indeed completed proof-of-concept and some safety studies - You are at the point of design and conduct of definitive toxicology studies - You have defined the manufacturing process to be used for the clinical studies and developed assays and preliminary lot release criteria - The pre-clinical testing and manufacturing process for your product uses the same or a similar platform as for other product(s) you have previously submitted to the Office of Therapeutic Products (OTP) Clinical data exists from previous studies for the same product and clinical indication - You have indeed completed proof-of-concept and some safety studies - You are at the point of design and conduct of definitive toxicology studies - You have defined the manufacturing process to be used for the clinical studies and developed assays and preliminary lot release criteria - The pre-clinical testing and manufacturing process for your product uses the same or a similar platform as for other product(s) you have previously submitted to the Office of Therapeutic Products (OTP) - Clinical data exists from previous studies for the same product and clinical indication Some other reasons for INTERACT meeting denials include: [[1]](/v1/docs/ref-interact-meeting) - A meeting was previously held for the same asset, and no substantially new information has been added - Missing meeting package in the meeting request - Meeting package is deficient or has too many gaps, limiting the ability for constructive feedback during the meeting - The feedback requested is outside the scope of the INTERACT meeting. For instance, if questions included in the package are solely focused on jurisdiction or regulatory pathway. OTP does not use INTERACT meetings to answer questions about: - Whether a product is appropriately regulated as a drug, device, and/or biological product or combination product, or what Center or Office should be the lead in review. For these questions, contact the OTP Policy Group at [OTP_ADP@fda.hhs.gov](mailto:OTP_ADP@fda.hhs.gov) or submit a Request for Designation (RFD) (see [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how- write-request-designation-rfd](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-request-designation-rfd)). - Whether it is appropriately regulated solely under Section 361 of the PHS Act and regulations in 21 CFR Part 1271. For these questions, visit the Tissue Reference Group website at [https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/tissue-reference-group](https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/tissue-reference-group) or contact the Tissue Reference Group in OTP at [TissueReferenceGroup@fda.hhs.gov](mailto:TissueReferenceGroup@fda.hhs.gov) Now that you know the most common causes for concern, you can proceed to your INTERACT meeting planning with the necessary information.