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

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products.'' The 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, which is currently being implemented 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 the Food and Drug Administration Modernization Act of 1997, and is intended to reduce unnecessary burdens for industry without diminishing public health protection.