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Executive Summary

FDA's NDA reg rewrite stipulates that an observed increase in the frequency of adverse drug reactions should be reported to the agency, according to a Dec. 11 HHS press release announcing that Secty. Heckler had signed-off on the document. According to the HHS release, a "significant increase in frequency" of adverse drug reactions would trigger the reporting requirements in the revised regulations. The requirement represents an addition to the reg revision proposal developed by the agency. Under the agency's original proposal, NDA applicants would have been required to report fatal or life-threatening adverse events within 15 working days, and the remainder of events within 30 days. The agency is eliminating the 30 days reporting requirement while retaining the 15 day report. According to HHS, "reports of significant increase in frequency of reactions to a drug will be required as soon as they are observed. Reports of serious, unexpected reactions will continue to be required as soon as details are known, in all cases within 15 working days." HHS said reports of other reactions "will be required every three months for three years after approval, up from one year." The release noted some of the major changes that were addressed in the proposed reg, such as new drug approval on the basis of foreign clinical data, NDA application format, and resolution of differences between FDA and drug sponsors. For instance, the new NDA application will require more focused and better organized analyses of data and will also allow "simultaneous review by FDA's several disciplines (clinical, pharmacological, chemical, statistical and biopharmaceutical)." FDA will assess approvability of an application 180 days after it is received, HHS pointed out. The reg includes a new procedure for a meeting between FDA scientists and company representatives "to resolve differences when a drug appears unapprovable." HHS noted that "most of the NDA requirements will become effective 90 days after publication, with a transition period of up to one year for certain requirements."

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