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October 25, 1985

Drug review, approval process changing

JAMA. 1985;254(16):2221-2227. doi:10.1001/jama.1985.03360160049009

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The FDA made news this year when it put into effect substantial revisions of the regulations that govern the drug review and approval process. The revisions have altered the way drug manufacturers submit marketing applications, making them smaller and more focused on the needs of particular reviewers; emphasized the FDA's willingness to rely on good foreign data; required that the safety part of pending marketing applications be updated while the applications were under review; and, in general, were designed to make the review process more efficient without impairing its quality.

The operating units of the FDA most affected by the new regulations, says Robert J. Temple, MD, director of the Office of Drug Research and Review, are his office and its counterpart for biologics, the Office of Biologics Research and Review. These two units are responsible for the evaluation and approval or nonapproval of all new drugs and biologics.