ICH announces new topics, draft guidelines for consultation
Regulatory NewsJoanne S. Eglovitch
Advanced therapies/cell and gene therapyBiologics/ biosimilars/ vaccinesChemistry, Manufacturing and Controls (CMC)Clinical TrialsGenericsGlobalGuidanceHealth Authority meeting and communication strategyHuman cells, tissues, and cellular and tissue-based products (HCT/Ps)ICHNotified BodiesPharmaceuticalsQuality Assurance and ControlRWE/RWD