IND Exemptions for marketed products [ 21 CFR b)] IND Exemptions for BA or BE studies [ 21 CFR b) (c) and (d)] [ and ].
This application contains the following items: (Check all that apply). B 1. Form FDA 1571 [ 21 CFR [a 2. Table oi Contents [ 21 CFR.
6. Protocol(s) [ 21 CFR a. Study protocol(s) [ 21 CFR b . Investigator data [ 21 CFR b)] or completed Form(s) FDA. seven card stud high-low 8-or-better controlled trials, detailed information on such trials that is relevant to an assessment of the drug's effectiveness for the proposed investigational use s should also be provided. In the case of any discrepancy in meaning, the English version is considered official.