REGULATORY CALENDAR

NoticesFood and Drug Administration announced the availability of a guidance for industry titled Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring to help sponsors develop strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof to enhance human subject protection and the quality of clinical trial data. The guidance is available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Submit comments at any time to http://www.regulations.gov or to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852. For more information, contact Ann Meeker-O’Connell, Center for Drug Evaluation and ...