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Regulations & Compliance

Pharmacovigilance

The science and activities relating to detection, assessment, understanding, and prevention of adverse drug effects. Required for all FDA-approved drugs, including post-marketing surveillance (Phase 4).

Frequently Asked Questions

What is Pharmacovigilance?
The science and activities relating to detection, assessment, understanding, and prevention of adverse drug effects. Required for all FDA-approved drugs, including post-marketing surveillance (Phase 4).
Why is Pharmacovigilance important in peptide research?
Understanding pharmacovigilance is crucial for navigating the legal and regulatory landscape of peptide use. Regulatory knowledge helps practitioners and patients distinguish between approved therapies, compounded medications, and research chemicals.

Related Terms

Adverse event reporting

The systematic reporting of negative health effects associated with drug use. Healthcare providers and manufacturers are required to report serious adverse events to the FDA via the MedWatch system.

FDA approved

A designation indicating the U.S. Food and Drug Administration has determined a drug is safe and effective for its labeled indication based on clinical trial evidence. FDA-approved peptides include semaglutide, tirzepatide, liraglutide, and PT-141.

Clinical trial phases

The staged process of testing a new drug in humans: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (large-scale confirmation), and Phase 4 (post-marketing surveillance). Each phase has specific objectives and requirements.

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