Subpart A - General Information

§ 99.1 - Scope.

§ 99.3 - Definitions.

Subpart B - Information To Be Disseminated

§ 99.101 - Information that may be disseminated.

§ 99.103 - Mandatory statements and information.

§ 99.105 - Recipients of information.

Subpart C - Manufacturer's Submissions, Requests, and Applications

§ 99.201 - Manufacturer's submission to the agency.

§ 99.203 - Request to extend the time for completing planned studies.

§ 99.205 - Application for exemption from the requirement to file a supplemental application.

Subpart D - FDA Action on Submissions, Requests, and Applications

§ 99.301 - Agency action on a submission.

§ 99.303 - Extension of time for completing planned studies.

§ 99.305 - Exemption from the requirement to file a supplemental application.

Subpart E - Corrective Actions and Cessation of Dissemination

§ 99.401 - Corrective actions and cessation of dissemination of information.

§ 99.403 - Termination of approvals of applications for exemption.

§ 99.405 - Applicability of labeling, adulteration, and misbranding authority.

Subpart F - Recordkeeping and Reports

§ 99.501 - Recordkeeping and reports.