Industry Applauds FDA Plan For Faster Cancer-Drug Review

Review But many critics are urging still other changes, including easier approval of 'off-label' uses DÉJÀ VU: NCI's David Parkinson sees parallels with AIDS drug testing. By Oncologists, industry officials, and cancer-patient advocacy organizations are applauding recently announced policy changes at the Food and Drug Administration (FDA) that speed up the approval process for cancer drugs. The plan, announced on March 29 by President Bill Clinton, aims to immediately streamlin

Steven Benowitz

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Review But many critics are urging still other changes, including easier approval of 'off-label' uses

DÉJÀ VU: NCI's David Parkinson sees parallels with AIDS drug testing.

By Oncologists, industry officials, and cancer-patient advocacy organizations are applauding recently announced policy changes at the Food and Drug Administration (FDA) that speed up the approval process for cancer drugs. The plan, announced on March 29 by President Bill Clinton, aims to immediately streamline the drug-approval process and broaden availability of cancer treatments.

Proponents of the changes contend they will expedite patients' access to potentially life-saving medications.

STEPPING UP: Jefferson University's Robert Comis supports reform. "There's always been a concern about the time for getting a drug approved to go from development to the marketplace," says Robert L. Comis, Ludwig A. Kind Professor of Medicine and director of clinical programs at Philadelphia-based Thomas Jefferson University's Kimmel Cancer Center. Comis, who attended the White House ...

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