NDA FORMAT GUIDELINES: EXCLUDING SUBMISSION OF NON-NDA STUDIES

Executive Summary

NDA FORMAT GUIDELINES: EXCLUDING SUBMISSION OF NON-NDA STUDIES would eliminate the possibility of public disclosure of confidential information, PMA contended in recent comments on FDA's draft guideline for the organization and content of the NDA clinical data section. The assn. told the agency: "It must be pointed out that further development plans for any drug are confidential proprietary information and are not appropriate for inclusion in an application." The FDA draft of the NDA format guideline states that the clinical data section "should include a discussion of any planned evaluation of additional potential indications, such as those approved for related drugs but not yet evaluated for the drug that is the subject of the application." In addition, the draft guideline requires that the filing company report "uses of the new drug or related drug that are fairly widespread but not approved for any agent." PMA pointed out the potential competitive damage that could occur if an NDA sponsor's plans for the drug are disclosed. "If such information were included in the summary basis for approval or otherwise became relasable under freedom of information, the significant economic impact to and the competitive disadvantage for, the applicant is self-evident."