``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

摘要

The Food and Drug Administration (FDA) is announcing the availability of a 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 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 an allergenic extract or allergen patch test. 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.