Last Updated : December 7, 2015
To be eligible for the Scientific Advice Program, applications are required be to filed online prior to initiation of the pivotal trials for which advice is being sought, at a time when adjustments can still be made to trial protocols based on the feedback received.
Eligible for Scientific Advice | Not Eligible for Scientific Advice |
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New drug products | Generic drugs |
Existing drug products with new indications | Preventive vaccines |
Drugs for rare diseases | Subsequent entry biologics (SEBs) |
Oncology products |