Draft ``Guidance for Industry: On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test''; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test.'' The draft guidance document, when finalized, is intended to provide guidance to applicants who wish to market an allergenic product or allergen patch test for the completion of the chemistry, manufacturing and controls (CMC) section and the establishment description section of revised Form FDA 356h entitled ``Application to Market a New Drug, Biologic, or an Antibiotic for Human Use.'' This draft guidance document is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives and the Food and Drug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 on industry without diminishing public health protection.