News & Analysis on Clinical Trial Services & Contract Research And Development
The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.
Caligor Opco LLC is providing regulatory and logistical management for Puma Biotechnology’s expanded access program (EAP) for its investigational breast cancer therapy, neratinib.
Randomized controlled trials are the fastest way to identify vaccines in an outbreak, but more collaboration is needed among international researchers – including CROs.
TransCelerate has chosen the Veeva Vault SiteExchange to simplify investigative site collaboration as part of its Shared Investigator Platform Initiative.
Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.