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FDA Wants To Help You Develop Drugs

 
• By Mary Jo Laffler

The agency’s report on innovative drug approvals in FY 2012 documents the successful performance metrics for the 35 novel medicines, including first-cycle review rates and on-time user fee targets, but it notes that a larger problem lies in early stages of drug discovery and development – and it thinks it can help.

Keeping up with its workload and approving novel drugs is not enough to ensure that a steady stream of truly innovative medicines reaches patients; FDA recognizes that it should do more to help in the early phases of drug development that have the highest failure rates.

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