FDA Notifies OMB Of Compounding Research With Maryland, Hopkins

FDA on Tuesday (May 7) sent a notice to the White House budget office about the agency’s plan to work with large research universities to evaluate whether a clinical need exists for certain bulk drug substances to be compounded at outsourcing facilities. As FDA originally announced in September, the agency’s research study with Johns Hopkins University (JHU) will focus on evaluating the effectiveness of six bulk drug substances used in compounded drugs to treat autism spectrum disorder. Meanwhile, the study...