Recently Posted FDA Guidance Documents on medical devices, botanical drugs, vaccines, drugs

Recently posted guidance documents

8/4/15: Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis - Guideline for Industry and Food and Drug Administration Staff

8/14/15: Rare Diseases: Common Issues in Drug Development Guidance for Industry

8/14/15: Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for Industry

8/14/15: Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements - Guidance for Industry and Food and Drug Administration Staff

8/14/15: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses - Draft Guidance for Industry and Food and Drug Administration Staff

8/14/15: Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and Food and Drug Administration Staff

8/14/15: Botanical Drug Development: Guidance for Industry

8/17/15: Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff

8/17/15: Uncomplicated Gonorrhea: Developing Drugs for Treatment

8/18/15: Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and Food and Drug Administration Staff

8/18/15: Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines - Guidance for Industry

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