Pharmaceutical companies must ensure the safety and effectiveness of their products even after FDA approval and U.S. market entry. This ongoing responsibility is managed through post-market reporting and pharmacovigilance programs, which play a critical role in identifying, assessing, and mitigating potential risks associated with human and veterinary drugs.

The U.S. Food and Drug Administration (FDA) requires manufacturers, distributors, and importers to submit adverse event reports for both prescription and over-the-counter (OTC) drugs. These reports help the FDA monitor product safety and take corrective actions when necessary, such as updating labeling, issuing safety communications, or initiating recalls.

Key post-market reporting requirements include:

• FAERS (FDA Adverse Event Reporting System): Used for monitoring adverse events, medication errors, and product safety trends.
• MedWatch Program: FDA’s voluntary and mandatory reporting system for healthcare professionals, patients, and manufacturers.
• Serious Adverse Event Reporting: Mandatory submission of life-threatening, fatal, or medically significant adverse events within strict timelines.
• Periodic Safety Update Reports (PSURs): Continuous monitoring and submission of cumulative safety data to FDA.
• Risk Management & Mitigation Plans (REMS): Required for certain drugs to ensure benefits outweigh risks.

At XPRO America, we provide expert support for pharmacovigilance and FDA reporting compliance. Our services include:

• Establishing compliant adverse event reporting systems for drug manufacturers and distributors.
• Assisting with MedWatch and FAERS submissions.
• Developing standard operating procedures (SOPs) for pharmacovigilance activities.
• Supporting post-inspection corrective actions for FDA findings.
• Preparing companies for safety audits and pharmacovigilance inspections.

With growing FDA oversight, strong pharmacovigilance practices are no longer optional—they are mandatory for market sustainability. By partnering with XPRO America, companies can reduce compliance risks, maintain FDA trust, and protect patient safety.

XPRO America provides FDA pharmacovigilance & post-market reporting support. Stay compliant with FAERS, MedWatch, and adverse event reporting requirements.