FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: SPONSOR RESPONSIBILITIES-SAFETY REPORTING REQUIREMENTS AND SAFETY ASSESSMENT FOR INVESTIGATIONAL NEW DRUG APPLICATION AND BIOAVAILABILITY/BIOEQUIVALENCE STUDIES; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Dec. 16 -- Food and Drug Administration has issued a notice called: Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability.

The notice was published in the Federal Register on Dec. 16 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled "Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies." The guidance...