Surrogate marker guidelines at hand

Surrogate marker guidelines at hand Coincident to the pending decision by Immunization Products Ltd. on whether to seek accelerated FDA approval of its HIV therapeutic vaccine, the agency is close to completing a year-long review of its guidelines for use of surrogate markers.

The FDA Office of Drug Evaluation is completing the formal guidelines and will release them in several weeks, according to office director James Bilstead. Bilstead, who is drafting the guidelines, told BioCentury that they will "expand on and formalize current policy." He is incorporating staff comments after circulating an initial draft through the FDA. The final draft will be re-circulated at the agency and then released to the public. Bilstead said the FDA has not decided how the guidelines will be released...