Module 3 - Strategic case studies in practice

Controls and Establishment Description Information for a Biological In Vitro Diagnostic Product (March 1999)

FDA Guidance for Industry on the Content and Format of Chemistry, Manufacturing, and Controls and Establishment Description Information for Allergenic Extract or Allergen Patch Test (April 1999) FDA Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the FDA Form 356h, Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use (May 1999)

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