Day 3 (Sep 6) Advanced Biopharmaceuticals Policy and Quality Forum Q&A
Please refer to the table below.
| 연사: Peter Marks (FDA) |
| Q1 | In
the case of INTERACT meetings, the guidelines are very vague as to what level
of data must be required to enable a pre-pre IND meeting. I wonder at least
what level of data and items I should submit to discuss with the
regulatory agency. |
| A1 | The
agency is somewhat flexible regarding the amount of information needed for an
INTERACT meeting. First and foremost,
these must be on a specific product.
Having some preclinical data is quite helpful as well. For additional information about this
program please see more details at:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-interact-meetings |
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