"Guidance for industry: content and format of chemistry, manufacturing and controls information and establishment description information for a biological in vitro diagnostic product;" availability. Food and Drug Administration, HHS. Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product." The guidance document is intended to provide guidance to applicants on the content and format of the chemistry, manufacturing and controls (CMC) and establishment description sections of the "Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use" (revised Form FDA 356h) for a biological in vitro diagnostic product. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and the FDA Modernization Act of 1997, and is intended to reduce unnecessary burdens for industry without diminishing public health protection.