Industry Groups Seek Clarity On FDA's Draft Waiver Guidance Under DSCSA

Pharmaceutical industry groups want more direction on how non-direct trading partners will be notified that a drug has been granted a waiver, exception or exemption (WEE) request under DSCSA so that good product is not deemed suspect and thrown out. There were also calls to expand the list of drugs eligible for exemption to include temperature-sensitive drugs as well as orphan drugs.