Some of the Pharmacovigilance-related Guidances planned to be Published in 2014 (New & Revised)

• Content, Format and Submission of Adverse Event Reports by Human Drug Compounding
• Providing Regulatory Submissions in Electronic Format – Postmarketing Safety Reports
• Adverse Events: Collection and Reporting for Secondary Endpoints
• Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format Version: 31 January 2014
• Labeling for Human Prescription Drug and Biological Products Approved Under Accelerated Approval
• Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling
• Pregnancy, Lactation, and Females and Males of Reproductive Potential: Labeling for Human
• Applying the Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
• Integrated Summary of Safety
• Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation
• Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
• Use of a Master File for Shared System Risk Evaluation and Mitigation Strategies

Full list available at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM314767.pdf