Industry wants clarity on scope of ICH stability testing guideline, timing of studies
Regulatory NewsJoanne S. Eglovitch
Advanced therapies/cell and gene therapyBiologics/ biosimilars/ vaccinesChemistry, Manufacturing and Controls (CMC)ComplianceICHManufacturingOTCPharmaceuticalsProduct LifecycleQuality Assurance and ControlSubmission and registrationUnited StatesUS Food and Drug Administration (FDA)