FDA Guidance Documents Update

Recently posted guidance documents:

Biologics

9/8/16:Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry

9/16/16: Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry

Drugs

9/8/16: S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic   

9/8/16: E17 General Principles for Planning and Design of Multi-Regional Clinical Trials

9/12/16: Guidance Agenda: Guidances CDER is Planning to Publish during Calendar Year 2016

9/14/16: Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Guidance for Industry

9/15/16: Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for Industry

9/16/16: S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers

Medical Devices

9/12/16: 510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations

Animal & Veterinary

9/16/16: CVM GFI #171 Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles

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