BRMACBiological Response Modifiers Advisory Committee
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The FDA had asked the BRMAC to explore the risks and potential benefits of x-SCID trials and other trials using retroviral vectors, and to focus on what new safety measures might be employed to minimize the risk of continued and future trials utilizing related technologies.
The BRMAC did not call for restricting all gene therapy trials, however.
Amgen, Inc., Thousand Oaks, CA, announced the Biological Response Modifiers Advisory Committee (BRMAC) to the Food and Drug Administration (FDA) has recommended approval of Stemgen, an early-acting blood cell growth factor discovered by Amgen's scientists for use in the treatment of cancer patients receiving stem cell transplants.