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