White Papers
SafetyCall prides ourselves on our knowledge and leadership in the arena of product safety and regulatory mandates concerning adverse event management. Click the links below and read some of our industry papers and abstracts from various publications and conferences.
Retailer Responsibilities
The FDA has recently stepped up enforcement regarding Adverse Event compliance for all responsible parties and issued 483 citations, warning letters and applied other sanctions. For those retailers with private labeled products nearing their name, proactively reviewing roles and responsibilities between all parties will help ensure full regulatory compliance.
Mandatory-Adverse-Event-Reporting-Retailer-Responsibilities.pdf
Adverse Event Reporting and Best Practices for Dietary Supplement Post-Market Surveillance
There are many companies who do a great job of documenting and reporting their serious adverse events; however, with the FDA recently citing statistics from their enforcement division that up to 70% of dietary supplement companies have Good Manufacturing Practice (GMP) deficiencies, along with concerns about underreporting of adverse events, it’s time for supplement manufacturer management to review their internal process and why it’s important to the product life cycle.
Abstracts and Presentations
| Abstract Title | Download |
|---|---|
| Recalls: Trends, Management, Opportunity and Challenges | Download “Recalls: Trends, Management, Opportunity and Challenges” – 984.17 KB |
| Workshop on Potential Health Hazards Associated with Consumption of Caffeine in Food and Dietary Supplements | |
| Best Practice Post-Market Surveillance for a Food Ingredient/Product | Download “Best Practice Post-Market Surveillance for a Food Ingredient/Product” – 72.06 KB |
| GAO/OIG Supplement Adverse Event Report Implications | Download “GAO/OIG Supplement Adverse Event Report Implications” – 70.22 KB |
| Botanical Risk Assessment for Quality and Safety | Download “Botanical Risk Assessment for Quality and Safety” – 69.01 KB |
| Are Botanical Safer Now? | |
| The Anatomy of Spontaneously Reported Dietary Supplement Adverse Events | Download “The Anatomy of Spontaneously Reported Dietary Supplement Adverse Events” – 67.97 KB |