FDA has issued a final guidance for sponsors and investigators regarding its enforcement of the agency’s final rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.” The rule amended IND reporting requirements under 21 CFR part 312 and added safety reporting requirements for persons conducting bioavailability and bioequivalence studies under 21 CFR part 320, states the guidance. The final rule was released in September 2010 and took effect in March 2011. Enforcement of the reporting requirements outlined in the final rule will begin on Sept. 28, 2011. The final guidance replaces the draft guidance that was issued with the rule in September 2010.
The Pharmaceutical Inspection Cooperation Scheme (PIC/S) celebrated its 40th anniversary on May 31, 2011, in Geneva, Switzerland. More than 160 individuals, including FDA Commissioner Margaret Hamburg, from around the world participated in the event. FDA’s participation was unique as it symbolized its recently accepted membership to the cooperation scheme. Also new to PIC/S is the Ukraine State Inspectorate. PIC/S is a global collaboration representing 39 competent authorities and focuses on GMP inspections of pharmaceutical manufacturing sites. PIC/S also works with the European Commission and has partnership agreements with regulatory and global health bodies such as EMA, EDQM, UNICEF, and WHO, and works with industry and academic groups globally on training programs.