Recently Posted Guidance Documents on Drugs, Devices, and Recalls

Drugs

• 9/28/2018 Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications Guidance for Industry and FDA Staff
• 9/28/2018 Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
• 9/28/2018  Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
• 9/28/2018 Adaptive Design Clinical Trials for Drugs and Biologics
• 9/25/2018 Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry
• 9/25/2018 Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry
• 9/25/2018 Insanitary Conditions at Compounding Facilities Guidance for Industry
• 9/24/2018 Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications
• 9/24/2018 ANDA Submissions — Content and Format of Abbreviated New Drug Applications

Devices

• 9/28/2018 The Special 510(k) Program - Draft Guidance for Industry and Food and Drug Administration Staff
• 9/25/2018 Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics - Guidance for Industry and Food and Drug Administration Staff

Recall

• 9/26/2018 Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls