SUBPART A—General Provisions (§158.1 to §158.80)
- 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.