FDA Updates Policies for its Controlled Substances Reviewers

The FDA released updated guidelines for its Controlled Substances Staff and outlined their role and responsibilities in the review process.

CSS assesses abuse potential, dependence liability and scheduling for CDER’s review of INDs, NDAs, ANDAs and BLAs — reviewing drugs such as opioids, hallucinogens and anabolic steroids that impact the central nervous system.

Under the revision to the agency’s 2003 guidelines, CSS staff will evaluate nonclinical and clinical dependence studies as well as human abuse potential studies, according to CDER’s updated Manual of Policies and Procedures.