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.
However, Amgen notes the BRMAC also voted that the use of Stemgen to reduce the number of aphereses is not indicated.
Boro Dropulic, Founder and Chief Scientific Officer of VIRxSYS, commented, "VIRxSYS has met the extensive requirements of the RAC committee of the NIH, the BRMAC committee of the FDA, and the FDA regarding appropriate pre-clinical safety testing of its VRX496 vector.