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Accutane Link To Depression Needs Further Study, FDA Committee Says

Executive Summary

Roche should use pharmacogenomic techniques to explore the potential link between Accutane and depression, FDA Dermatologic & Ophthalmic Drugs Advisory Committee consultant Robert Branch, MD, University of Pittsburgh Medical Center, suggested.

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FDA is not approving some prescription drugs because of a lack of confidence in labeling restrictions to ensure appropriate prescribing behavior, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said during a National Public Radio interview Dec. 19.

FDA Approval Decisions Changing In Light Of Relabeling Failures - Woodcock

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