The Food and Drug Administration (FDA) releases a final guide dated February 2012 titled “Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information.” The guidance finalizes draft guidance of the same title dated September 2010.
The Food and Drug Administration (FDA) announces the availability of final product-specific bioequivalence (BE) recommendations that “provide product-specific guidance on the design of BE studies to support abbreviated new drug applications.” FDA requests comments at any time. The agency also issues additional draft and revised draft product-specific BE recommendations. FDA requests comments by April 23, 2012.
The Food and Drug Administration (FDA) corrects a docket number appearing in a February 15, 2012, Federal Register notice announcing an opportunity for public comment on a proposed collection of information on a potential “biosimilar product and an application for a supplement for a proposed interchangeable product.” The corrected number is ‘‘[Docket No. FDA–2012–N–0129].’’ Comments on the original notice about section 351(k) biosimilar applications are requested by April 16, 2012.
The U.S. Department of Agriculture announces a March 5-6, 2012, meeting in Washington, D.C., of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21). Agenda items include “progress of the four AC21 working groups on analyses relevant to the overall AC21 charge [and] how the commercial sector is addressing unintended presence now and managing risk.”