Subpart A. Subpart A—General Provisions

• § 158.1 - Purpose and scope.
• § 158.3 - Definitions.
• § 158.5 - Applicability.
• § 158.30 - Flexibility.
• § 158.32 - Format of data submissions.
• § 158.33 - Confidential data.
• § 158.34 - Flagging of studies for potential adverse effects.
• § 158.45 - Waivers.
• § 158.60 - Minor use data policies.
• § 158.70 - Satisfying data requirements.
• § 158.75 - Requirements for additional data.
• § 158.80 - Use of other data.