“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.

Not all technology platforms provide the expected benefit of filling in CMC review gaps and speeding coronavirus vaccine approvals.