Business · 12/09/2018

FDA Proposes Repeal of Irradiation Regulation for Sterilized Drugs

The US Food and Drug Administration (FDA) is proposing to repeal a regulation requiring an approved new drug application for drugs sterilized by irradiation, allowing over-the-counter (OTC) products to be marketed without approval, as long as they comply with current good manufacturing practices (CGMPs) and are generally recognized as safe and effective.