Product Safety and Signal Evaluation
Explore all topics, guides, and frameworks related to Product Safety and Signal Evaluation.
Articles in this section
2- Recombinant ADAMTS13: Immunogenicity, Neutralising Antibodies and Loss of Effect Explains why anti-ADAMTS13 antibodies can compromise enzyme replacement and precipitate recurrent cTTP, distinguishes binding antibodies from neutralising inhibitors, and traces how trial limitations and post-marketing reports led to a US boxed warning. Provides a jurisdiction-aware framework for case intake, causality assessment, signal evaluation and risk control. Read Article →
- Ferric Carboxymaltose: Hypophosphataemia, Osteomalacia and Post-Marketing Risk Explains how ferric carboxymaltose can cause renal phosphate wasting and, in some patients, persistent hypophosphataemia with osteomalacia or fractures. It connects mechanistic and comparative clinical evidence with the 2026 FDA boxed warning, the ongoing EU Article 31 review, practical safety surveillance, and proportionate risk controls. Read Article →