Module 1administrativendaind● High priority
1.3.3 — Debarment Certification
Debarment certification under Generic Drug Enforcement Act
Requirements by Phase
Phase 1
required
Phase 2
required
Phase 3
required
NDA
required
Debarment certification under Generic Drug Enforcement Act
Requirements by Phase
IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required
Content Requirements
- Certification that no person who has been debarred under the Generic Drug Enforcement Act is involved in the application
- List of all persons involved in development and submission
- Statement of compliance with FD&C Act Section 306
Expected Deliverables
- Debarment certification letter
ICH Guidelines: 21 CFR 312.23, FD&C Act Section 306
Source: 21 USC 335a
References
Related Sections
Up to1.3 — Administrative Information1.3.1 — Cover Letter
Cover letter identifying the submission type and key information
1.3.2 — Financial Disclosure
Financial disclosure forms (Form 3454/3455) for clinical investigators
1.3.4 — Environmental Assessment
Environmental assessment or categorical exclusion claim
1.3.5 — Patent and Exclusivity Information
Check your compliance against this section
Upload your study data and get instant gap analysis with specific regulatory citations.
Try Compliance Check