Joanne S. Eglovitch
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Latest From Joanne S. Eglovitch
The compliance chief for FDA’s center for drugs said API makers need to do a better job of testing their products for impurities to avoid exposing patients to safety risks, as has occurred with at least one supplier’s valsartan API.
FDA Aims For Transparency In Releasing New Risk-Based Site Selection Model For Determining Who Is Inspected Next
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.