Recently posted guidance documents
10/30/15: Homologous Use of Human Cells, Tissue, and Cellular and Tissue-Based Products; Draft guidance for Industry and FDA Staff
11/2/15: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment
11/2/15: Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens - Guideline for Industry and Food and Drug Administration Staff
11/2/15: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
11/5/15: Minutes of Institutional Review Board (IRB) Meetings - Draft Guidance for Institutions and IRBs
11/2/15: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment
11/2/15: Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens - Guideline for Industry and Food and Drug Administration Staff
11/2/15: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
11/5/15: Minutes of Institutional Review Board (IRB) Meetings - Draft Guidance for Institutions and IRBs
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