CDER’s safety chorus
FDA this month provided added color on the increased role and responsibilities of the Office of Surveillance and Epidemiology in working with the Office of New Drugs to address safety issues. There has been a significant shift toward giving an equal voice to agency staff across the disciplines.
Members of OND, which is responsible for drug reviews, and OSE, the agency’s drug safety office, have in the past found themselves at loggerheads over safety. A recent high-profile example is the controversy over the strength of evidence about the cardiovascular