What are FDA’s Guiding Principles of Good AI Practice in Drug Development?

Here they are: Human-centric by design. The development and use of AI technologies align with ethical and human-centric values.Risk-based approach. The development and use of AI technologies follow a risk-based approach with proportionate validation, risk mitigation, and oversight based on the context of use and determined model risk.Adherence to standards. AI technologies adhere to relevant…

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Presbyopia Eye Drop From Startup Tenpoint Gets FDA Approval, Paving Way for $235M Financing

Tenpoint Therapeutics’ Yuvezzi brings a combination approach to presbyopia compared to single mechanisms of action offered by once-daily eye drops from Orasis Pharmaceuticals, Lenz Therapeutics, and AbbVie. Yuvezzi’s commercialization will be supported by up to $235 million in financing. The post Presbyopia Eye Drop From Startup Tenpoint Gets FDA Approval, Paving Way for $235M Financing…

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