Draft ``Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products or Animal Plasma or Serum- Derived Products;'' Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products or Animal Plasma or Serum-Derived Products.'' The draft guidance document is intended to assist applicants in the preparation of the content and format of the chemistry, manufacturing, and controls (CMC) section and the establishment description section of a biologics license application (BLA), revised Form FDA 356h for human plasma-derived biological products, animal plasma, or serum-derived products. This action is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives and FDA Modernization Act of 1997, and is intended to reduce unnecessary burdens for industry without diminishing public health protection.