Pharmacovigilance (PV) is a critical aspect of public health and safety, focusing on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Under the guidance of the United States Food and Drug Administration (FDA), pharmacovigilance services are structured to ensure that medications on the market are safe and effective for public use.

The FDA has established comprehensive guidelines to ensure effective pharmacovigilance. These guidelines are outlined in various regulatory documents and guidance notes, including:

• The Code of Federal Regulations (CFR): Title 21 of the CFR outlines the requirements for adverse event reporting and record-keeping for pharmaceutical companies.

• FDA Guidance Documents: These documents provide detailed recommendations on best practices for conducting pharmacovigilance. Notable documents include the FDA’s guidance on “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment” and “Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products.”

• Adverse Event Reporting Systems (AERS): The FDA maintains databases such as the FDA Adverse Event Reporting System (FAERS) where adverse event reports are collected and analyzed.

• Risk Evaluation and Mitigation Strategies (REMS): The FDA may require a REMS for certain medications to ensure that the benefits outweigh the risks. REMS can include medication guides, communication plans, and elements to assure safe use (ETASU)

• MedWatch Program: The FDA’s MedWatch program allows healthcare professionals and the public to report adverse events and safety concerns directly to the FDA.

• Periodic Safety Update Reports (PSURs): Pharmaceutical companies must submit periodic safety reports to the FDA, summarizing the worldwide safety experience of a drug.

• Pharmacoepidemiologic Studies: The FDA may require or conduct post-marketing studies to assess drug safety in real-world settings. These studies can help identify rare or long-term adverse effects.