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FDA 'Pushing Envelope' on AIDS Drug
THE FOOD and Drug Administration (FDA) is "pushing the envelope" of drug development with its review of didanosine (DDI, Bristol-Myers Squibb Co, New York, NY), says FDA commissioner David Kessler, MD."This represents a milestone in drug review," he says. Just 3½ months after the company submitted its new drug application, the agency's antiviral advisory committee voted five to two to recommend approval for adult and pediatric patients with the acquired immunodeficiency syndrome (AIDS) who no longer respond to zidovudine (AZT, Burroughs Wellcome Co, Research Triangle Park, NC), the only licensed AIDS drug.The agency will act on the recommendation by the committee of outside experts in as short a time as possible, says Kessler.Another milestone was achieved by the agency's internal reviewers, who applied "innovative, sophisticated models" in analyzing uncontrolled data from phase I trials and an expanded-access compassionate distribution program,
Medical News & Perspectives. JAMA. 1991;266(6):757-768. doi:10.1001/jama.1991.03470060015002