FDA: Vaccine Makers Should Prepare for More Advanced Screening

The FDA is advising vaccine manufacturers to be ready for the findings of more sensitive analytical detection methods as it prepares to receive advice this week on applying such methods. Advanced screening techniques use nonspecific means to gather a large amount of data, Karen Midthun, acting CBER director, said at the 2010 Biotechnology Industry Organization International Convention. “The more sensitive the techniques one has ... the more likely one may be to find things,” and the FDA and industry need to be prepared for the findings, she said.
Washington Drug Letter