FDA Poised To Fund Study Evaluating Postmarket Risk Of Generic Drugs

FDA is looking to fund studies that would develop pharmacometric approaches that would help the agency's Office of Generic Drugs in the evaluation of postmarket risk and the interpretation of postmarket adverse event reports or product substitution complaints, according to a grant announcement earlier this week. This is one of the priority areas of the Generic Drug User Fee Act (GDUFA) Regulatory Research program. “The scope of the awarded study is being expanded to risk-based methodology on generic equivalents of...