Return to sender

Officials at the US Food and Drug Administration (FDA) in July announced a key change in the way they notify companies when their therapeutic product applications fall short. Instead of merely saying a product is 'not approvable', the FDA Center for Drug Evaluation and Research (CDER) will issue 'complete response' letters to product sponsors describing specific deficiencies and, when possible, recommending actions to address those deficiencies. Beyond bringing the practice for therapeutic products into line with current notification procedures for biologics, this new procedure also provides CDER with a “neutral way of conveying information to a company when we cannot approve a drug application in its present form,” says CDER director Janet Woodcock. Thus, this change is not expected to have much impact on biotech companies because the policy had been implemented earlier, according to a spokesperson for the Biotechnology Industry Organization in Washington. But some analysts predict these changes will add uncertainty to the drug review process, and may have a negative impact on stock values if it remains up to individual drugmakers to decide how much information from such letters to disclose.


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Fox, J. Return to sender. Nat Biotechnol 26, 961 (2008).

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