NIIMBL Aims To Help Manufacturers Perfect Next-Generation COVID-19 Vaccines
Public-private partnership could help coronavirus vaccine developers increase thermal stability, strengthen potency assays and fine-tune adventitious agent testing, among other things.
You may also be interested in...
Demand surges, supply surges and investigator travel restrictions are forcing FDA to adopt less restrictive regulatory approaches during the pandemic.
“Any practices that limit the social interaction between the investigator and the firm are always good,” says FDA ORA official Rachel Harrington. Donald Ertel, of FDA’s Center for Biologics Evaluation and Research, encourages firms to “try to maintain a one-way flow through the facility” for investigator plant walkthroughs.
Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.