FDA's NDA REWRITE MAY INCLUDE "END OF REVIEW CONFERENCE," FDA

FDA's NDA REWRITE MAY INCLUDE "END OF REVIEW CONFERENCE," FDA Acting Com. Novitch stated at a recent meeting of the Pharmaceutical Mfrs. Assn. Medical Section. Noting that the agency is seeking to expand communications between FDA and drug sponsors, Novitch said FDA is "considering adding a standard meeting called an 'end of review conference,'" to the NDA regs. He explained that the conference "would occur routinely, at the sponsor's option, after FDA has completed review of an NDA and has issued an action letter." Novitch said the goal of such a meeting would be "to reach a meeting of the minds on what additional data or analyses are necessary for a drug to be approved." He also pointed out that the new regs will establish, as PMA and others suggested, an ombudsman "to aid drug sponsors in resolving impasses of a procedural or administrative nature." He said an ombudsman would handle "difficulties in setting up meetings, getting responses to letters, or determining the status of an application in the review process." Novitch told attendees at the March 19 meeting that the NDA rewrite is at HHS and FDA is "very hopeful that a final rule might be published by early summer." Another priority at FDA is a revamping of the adverse drug reaction reporting system, Novitch observed. "Our goal is that by the end of this, we will have in place an on-line, interactive data base that will allow for immediate input, editing, and data retrieval," he stated. "Our new system will provide for accelerated data entry and will also allow for desired output on an 'as needed' basis." Novitch said the agency is revising the computer system and reorganizing paper flow internally.