21 CFR - Code of Federal Regulations - Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A: GENERAL

PART 25: ENVIRONMENTAL IMPACT CONSIDERATIONS

Subpart E: Public Participation and Notification of Environmental Documents

21 CFR 25.51 - Environmental assessments and findings of no significant impact.

21 CFR 25.52 - Environmental impact statements.

Subpart C: Categorical Exclusions

21 CFR 25.30 - General.

21 CFR 25.31 - Human drugs and biologics.

21 CFR 25.32 - Foods, food additives, and color additives.

21 CFR 25.33 - Animal drugs.

21 CFR 25.34 - Devices and electronic products.

Subpart D: Preparation of Environmental Documents

21 CFR 25.40 - Environmental assessments.

21 CFR 25.41 - Findings of no significant impact.

21 CFR 25.42 - Environmental impact statements.

21 CFR 25.43 - Records of decision.

21 CFR 25.44 - Lead and cooperating agencies.

21 CFR 25.45 - Responsible agency official.

Subpart F: Other Requirements

21 CFR 25.60 - Environmental effects abroad of major agency actions.

PART 26: MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

21 CFR 26.0 - General.

Subpart A: Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices

21 CFR Appendix A to Subpart A of Part 26 - List of Applicable Laws, Regulations, and Administrative Provisions

21 CFR Appendix B to Subpart A of Part 26 - List of Authorities

21 CFR Appendix C to Subpart A of Part 26 - Indicative List of Products Covered by Subpart A

21 CFR Appendix D to Subpart A of Part 26 - Criteria for Assessing Equivalence for Post- and Preapproval

21 CFR Appendix E to Subpart A of Part 26 - Elements to be Considered in Developing a Two-Way Alert System

21 CFR 26.1 - Definitions.

21 CFR 26.10 - Regulatory authorities not listed as currently equivalent.

21 CFR 26.11 - Start of operational period.

21 CFR 26.12 - Nature of recognition of inspection reports.

21 CFR 26.13 - Transmission of postapproval inspection reports.

21 CFR 26.14 - Transmission of preapproval inspection reports.

21 CFR 26.15 - Monitoring continued equivalence.

21 CFR 26.16 - Suspension.

21 CFR 26.17 - Role and composition of the Joint Sectoral Committee.

21 CFR 26.18 - Regulatory collaboration.