Megha Sinha, Kolter AI, discusses how pharma's AI bottleneck shifted from technology to readiness as execution across 60 ...
According to Schniepp, inspectors are not auditing the electronic submission mechanism itself because the eCTD system is ...
Regulatory Optimisation Group efforts are converging on a future-state lifecycle change process, shifting from document-based ...
Megha Sinha, founder and CEO of Kolter AI and Kamet Consulting Group, spoke with PharmTech at the beginning of 2026 about her ...
Novo Nordisk challenges nationwide Zepbound/Mounjaro advertising as misleading comparative promotion, citing omitted disclosure of the most effective FDA-approved semaglutide injectable doses. One ...
Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.
A 2026–2027 joint work program operationalizes EMA–EISMEA cooperation to move European Innovation Council-funded projects ...
A distributed “hub-and-spoke” operation could register as one establishment, reducing administrative friction while improving FDA visibility through required pre-notification of unit relocation and ...
Economic asymmetry after cartridge introduction drives a design philosophy centered on minimizing false acceptances and protecting API, with >99.5% first-pass yield as the principal success criterion.
Annex 1 is driving investments in HVAC, water/clean utilities, environmental monitoring, barrier technologies, and facility remediation, with true maturity defined by QRM altering capital ...
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