Module 1 2021

Possible Outcomes of IND Review

• No Action

− Passive Approval • Deficiency Letter − Identifies problems that might, if not resolved, potentially justify the use of clinical hold − Due to short review time, rarely used during 30 day review clock • Information Request Letter − Clarification request for more information whose absence would not justify a clinical hold • Advice Letter − Recommendations for ongoing or proposed clinical studies or protocols for which no response is necessary • Clinical Hold

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IND Status • Active − Development program is being actively pursued − Clinical investigations are ongoing • Inactive − Development program is not active • Sponsor request

• FDA Action ( No subjects entered in to clinical study for a period of 2 years; or all investigations under IND are on Clinical Hold for 1 or greater

• Clinical Hold − FDA order to delay suspend clinical investigations under IND • Withdrawn − Sponsor Action − All clinical investigations under IND must be discontinued • Terminated − FDA Action − IND deficiencies can not be resolved

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