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Regulatory Focus™ > News Articles > Meet BRUDAC, FDA's Old Committee With a New Name and Charge

Meet BRUDAC, FDA's Old Committee With a New Name and Charge

Posted 10 April 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced that its Advisory Committee for Reproductive Health Drugs (ACRHD) will, effectively immediately, be getting a name change.

Under a new charter announced on 10 April 2014, the committee will see its name changed to the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC), better reflecting its current scope of responsibilities, FDA said.

The new committee will review and evaluate data on human drug products intended to treat osteoporosis and metabolic bone disease, as well as those for use in obstetrics, gynecology, urology and related specialties. Those reviews will form the basis of recommendations to FDA on whether the product should later be approved.

The name was formally changed on 23 March 2014 when ACRHD/BRUDAC's charter was renewed, FDA noted, but the 10 April 2014 Federal Register notice codifies that change, FDA said.

Federal Register Notice

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