Guide to Safety Reporting for Drugmakers: FDA Adverse Event Requirements
Safety reporting is a critical step in the manufacture and sale of any pharmaceutical product. Without it, your drug will not only fall out of compliance, but it could cause serious consequences for consumers. With it, you can meet FDA expectations, bring a safe and effective product to market, and gain public trust in your drug.
This FDAnews compilation book on safety reporting is a comprehensive guide to answering the FDA’s requirements regarding adverse events, serious adverse events, adverse drug reactions, and postmarket benefit-risk evaluation reports. It contains details on what to report, how to report it, and when to file. You’ll also gain insights on understanding safety priorities, long-term follow-ups, and benefit-risk evaluation reports.
This unique compilation includes 17 resources, all imperative pieces in developing a safety reporting plan that works for you and your team. These include guides on postmarketing safety reporting for human drug and biological products, post-approval safety data management, and good pharmacovigilance practices and pharmacoepidemiologic assessment. The book also covers premarket risk assessments and the FDA’s Adverse Event Reporting System (FAERS).
In this book, we will cover:
- Adverse Event Basics
- Definitions of adverse drug reaction, serious adverse event, and life-threatening events
- How and when to file adverse event reports
- Filing periodic benefit-risk evaluation reports
- Postmarking safety reporting for human drug and biological products, including vaccines
- Post-approval safety data management
- Good pharmacovigilance practices and pharmacoepidemiologic assessment
- Premarketing risk assessment
- Answers on FDA’s Adverse Event Reporting System (FAERS)
- Guidance from the International Council on Harmonization (ICH)
- Center for Drug Evaluation safety priorities
- Safety reporting requirements for combination products
Reporting around safety is essential to your product moving forward successfully and remaining on the market. This compilation book is the guide you need to ensure you are following all FDA requirements and keeping consumers safe.
Take advantage of the expert tips, comprehensive framework, and precise details in this guidebook — and bring a safe, compliant product to the public.
Who Will Benefit
- Quality assurance staff
- Pharmacovigilance staff
- Regulatory and compliance staff
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