FDA Delays Safety Reporting for New Drugs for 6 Months

WASHINGTON (CN) – The Food and Drug Administration will delay for 6 months enforcement of safety reporting requirements for investigational new drugs and bioavailability and bioequivalence studies.     The agency has issued a guide informing sponsors and investigators that the agency intends to exercise enforcement discretion regarding the reporting requirements in the final rule, “Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Studies in Humans”, until Sept. 28, 2011.     Click on the document icon for this regulation and others.