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.