POLICY ON POST-APPROVAL STUDIES 1. Post-approval studies may be required to provide additional information on the efficacy, safety, and use of the drug in populations more diverse than included in the clinical trials conducted prior to approval of the new drug in accordance with the provisions of the rules. 2. Necessary guidance documents should o be developed to provide the extent of requirements ...

Design and development verification: Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained.