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FDA's NEW ADVERSE DRUG REACTION PROCESSING PROCEDURES

Executive Summary

FDA's NEW ADVERSE DRUG REACTION PROCESSING PROCEDURES give the agency on-line retrieval capacity for aggregate analysis of adverse drug reaction (ADR) reports, FDAer Wayne Turner, Office of Epidemiology & Biometrics, told a Drug Information Assn. workshop held in Washington, D.C. Oct. 18-20.Turner said the agency's aim "is to have all newly received reports accessible for on-line retrieval within one week after receipt." As part of FDA's effort to improve the processing of ADR reports, Turner noted that the Div. of Drug & Biologic Product Experience was reorganized and a new branch, the Adverse Reaction & Poisoning Surveillance Branch, created. The technical processing of ADR reports is now conducted by the adverse reaction section of the new branch rather than the Reports & Evaluation Branch. Turner explained that under the new procedure, ADR reports are mailed to the adverse reaction section, which forwards the reports to the reports evaluation branch for costarting assignment of FDA terminology for adverse reaction information). The reports are then returned to the adverse reaction section where they are keypunched into the data entry system in an unevaluated form."The day after the unevaluated reports are entered into the computer, the raw data are retrievable from the on-line system," Turner said. Turner added that mfr. 15-day reports and reports received directly from practitioners are returned to the reports evaluation branch for assessment of the presence of the reaction in current labeling, causality, severity and adequacy of the report. He said mfr. periodic reports will skip the evaluation process. The quality is reviewed and they are sent to update the master file. The FDAer also noted the agency's desire for mfrs. to submit ADR information on computer tapes. "We are formally announcing our desire and preparation to receive costarted adverse reaction data on computer tape." He pointed out that 15 day reports should not be submitted on tape. Turner said specifications for submitting and entering adverse reaction information into FDA's computer system have already been distributed to some companies who have expressed interest in computer tape submission.

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