FDA Approving More Novel Drugs Without Advisory Committee Review
By
Sue Sutter / Email the Author / “The Pink Sheet” Jan. 23, 2012, Vol. 74, No. 4
Year In Review And The Year Ahead / Word Count: 3518 / Article # 00120116007
Executive Summary
The Center for Drug Evaluation and Research is becoming more comfortable approving new molecular entities and novel biologics without first seeking the views of its outside experts. In 2011, 13 of the 30 novel therapeutics cleared did not undergo advisory committee scrutiny beforehand.
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