FDA Guidance Documents Update

Recently posted guidance documents:

8/9/16: Calorie Labeling of Articles of Food in Vending Machines, Draft Guidance for Industry

8/12/16: Calorie Labeling of Articles of Food in Vending Machines: Guidance for Industry; Small Entity Compliance Guide

8/15/16: Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery - Guidance for Industry and Food and Drug Administration Staff

8/15/16: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery - Guidance for Industry and Food and Drug Administration Staff

8/16/16: Regulatory Classification of Pharmaceutical Co-Crystals- Draft Guidance for Industry

8/23/16: Hazard Analysis and Risk-Based Preventive Controls for Human Food, Draft Guidance for Industry

8/24/16: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities, Draft Guidance for Industry

8/24/16: ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits

8/24/16: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, Guidance for Industry and Food and Drug Administration Staff

8/24/16: Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders

8/25/16: Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation

8/26/16: Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry

8/30/16: Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Guidance for Industry and Food and Drug Administration Staff

9/1/16: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - Guidance for Industry and Food and Drug Administration Staff

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