FDA Guidance Document Update

Recently Posted Guidance Documents

Drugs

11/17/16: BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry

11/21/16: Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments

11/22/16: Nonprescription Sunscreen Drug Products – Safety and Effectiveness Data

11/22/16: Contract Manufacturing Arrangements for Drugs: Quality Agreements

11/22/16: Safety Testing of Drug Metabolites

11/22/16: Nonprescription Sunscreen Drug Products – Format and Content of Data Submissions

11/23/16: Submission of Quality Metrics Data Guidance for Industry

11/28/16: Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)

Medical Devices

11/18/16: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff

11/29/16: Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes - Guidance for Industry and Food and Drug Administration Staff

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