Investigational New Drug Applications and New Drug Applications

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The Food and Drug Administration (FDA) is proposing to amend its regulations pertaining to investigational new drug applications (IND's) and new drug applications (NDA's). The proposed rule would clearly define in the NDA format and content requirements the need to present effectiveness and safety data for important demographic subgroups, specifically gender, age, and racial subgroups. The rule would codify expectations that FDA has previously described in guidance. The proposed amendments would also require IND sponsors of drugs, including biological products, to characterize, in their annual reports, the number of subjects in a clinical study according to age group, gender, and race. The proposed rule does not address the requirements for the conduct of clinical studies and would not require sponsors to conduct any more studies than they have already conducted. It also would not require the inclusion of particular numbers of individuals from specific subgroups in any study or overall. The rule refers only to the presentation of data already collected. The scope of this proposal does not extend to requiring additional studies or data. DATES: Written comments by December 7, 1995. A