1.5 — Application Status
Application status requests including withdrawal, inactivation, and reactivation
Requirements by Phase
Application status requests including withdrawal, inactivation, and reactivation
Requirements by Phase
IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: required
Content Requirements
- Withdrawal requests with justification
- Inactivation requests (IND placed on inactive status)
- Reactivation requests with updated information
- Status change justification and supporting documentation
Expected Deliverables
- Status request letter
ICH Guidelines: 21 CFR 312.23
Source: 21 CFR 312.23
References
Related Sections
Up toModule 1: Administrative Information and Prescribing InformationComplete table of contents for the submission
Cover letter identifying the IND submission type, serial number, and key information
Administrative information including contact details, certifications, and financial disclosures
Letters of authorization, right of reference statements, and cross-references to other applications
Meeting requests and minutes for pre-IND, pre-NDA/BLA, and Type A/B/C meetings
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