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for-pharma-sponsors
What is the postmarket pharmacovigilance volume scale Burna AI is built for?
FDA receives 2 million+ adverse drug reaction reports annually across all approved drugs. A large pharma company can process over a million ICSRs per year in-house. A single high-volume oncology drug can generate hundreds of thousands of postmarket ICSRs per year for the duration of its market life. Burna AI's postmarket module is architected for commercial-scale volume: real-time case processing, MedDRA coding, E2B(R3) submission output, and structured data feeding directly into safety signal detection.