March 10, 2010

Building Comparative Efficacy and Tolerability Into the FDA Approval Process

Author Affiliations

Author Affiliations: University of Rochester School of Medicine and Dentistry, Rochester, New York.

JAMA. 2010;303(10):979-980. doi:10.1001/jama.2010.257

The US Food and Drug Administration (FDA) “is responsible for protecting the public health by assuring the safety, efficacy, and security” of drugs and medical devices and for helping provide the public with the “science-based information” it needs to use drugs and devices to improve health.1 Under the current Code of Federal Regulations (CFR), new drug approval is typically based on demonstration of efficacy in 2 or more randomized clinical trials (RCTs), often in comparison with placebo; high-risk device approval appears to be based on considerably weaker evidence of safety and efficacy.2 Given the continued progress of science, approval of a new drug or device implies to physicians and the general public that the product represents an advance over older treatments.

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