We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The data integrity issues most likely to lead to a delay in FDA marketing approval for new drugs include poor quality control for data entry, systemic errors at clinical study sites — such as enrolling ineligible patients — and database changes made after an initial database lock and study unblinding. Read More
Industry trade group giants, PhRMA and BIO are nudging FDA to re-examine how it regulates off-label communication between drugmakers, health-care providers and payers. Read More