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FDA Approving More Novel Drugs Without Advisory Committee Review

 
• By Sue Sutter

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.

FDA is approving a higher percentage of new molecular entities and novel biologics without first seeking the views of its outside experts, despite the FDA Amendments Act’s emphasis on pre-approval advisory committee review of such therapies.

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