Tuesday, January 21, 2014

Study examines reasons for delay, denial of new drugs by FDA

Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable outcome measures for a study, accounted for significant delays in the approval of new drugs by the Food and Drug Administration (FDA), according to a study in JAMA. "The road from medical product discovery to marketing is typically long and costly. The interval between initial clinical testing and product approval has been estimated to average 8 years and only 1 in 6 drugs entering clinical trials ultimately obtains U.S.

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