FDA: General Scientific Knowledge Can Support, Speed Drug Approvals

Drug and biologic sponsors can, when appropriate, use so-called generally accepted scientific knowledge (GASK) about a drug and its effect on patients to support their product applications, FDA says in a recently published draft guidance that asserts the use of such knowledge can help streamline product development and speed drug approvals. “This may result in streamlined product development that avoids unnecessary animal testing, decreases a drug’s development costs, and quickens the drug’s time to approval and marketing -- and thus,...