1.3.4 — Environmental Assessment

Environmental assessment or categorical exclusion claim

Requirements by Phase

NDA: required

Content Requirements

• Environmental assessment per 21 CFR 25 (NDA)
• Categorical exclusion claim with justification (most INDs qualify)
• Analysis of environmental impact of manufacturing and use (if EA required)
• Mitigation measures for environmental impact (if applicable)

Expected Deliverables

• Environmental assessment or categorical exclusion claim

ICH Guidelines: 21 CFR 25

Regulatory Requirements (FDA IND PHASE 1)

• [Phase 1] For INDs submitted to CDER, see Guidance for Industry for the Submission of Environmental Assessments for Human Drug Applications and Supplements, November, 1995.

Regulatory Requirements (FDA IND PHASE 2 3 CMC)

• [Phase 2, Phase 3] Updates on environmental assessment information already submitted and on whether a claim for a previous categorical exclusion has changed should be provided.

Source: 21 CFR 25