WASHINGTON _ The FDA has started a pilot projectto test electronic submissions of drug applications toenhance the efficiency of the review process. The agencyis asking manufacturers to voluntarily submit electroniccopies of preclinical pharmacology and toxicologyreports in addition to paper submissions.

According to a notice published in the Aug. 30, 1995Federal Register, the FDA will require that allinvestigational new drug applications (IND) and newdrug applications (NDA) be submitted in computerreadable format if the pilot project is successful.

The FDA expects the project will prove to be most usefulwhen a drug is in the IND stage because of the largenumber of preclinical studies that are submitted duringthis period.

The pilot project was launched after talks between theFDA and the Pharmaceutical Research Manufacturers ofAmerica resulted in three companies volunteering tosubmit data electronically. FDA's Center for DrugEvaluation and Research, which is running the pilot, nowhas enough room on its local areas network to accept andreview seven additional electronic submissions.

The initiative will help facilitate rapid retrieval ofinformation contained in submissions and minimizestorage space. "Electronic documents and appropriatedocument retrieval software make possible indexing ofdocuments by content and rapid retrieval of documentscontaining the desired information," according to thenotice. FDA reviewers will be able to electronicallysurvey manufacturers' documents and copy or print thosesections of the document that are sought. n

-- Michele L. Robinson Washington Editor

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