Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track FDA submission for a first-in-class oncology drug via the Real-Time Oncology Review (RTOR) program—shortening timelines by two months.
The FDA ESG NextGen for Regulatory Submissions has replaced the FDA’s WebTrader and simplifies pharmaceutical registration and submission management.
FDA aims to replace animal testing in drug development with AI and lab-based models, enhancing safety, lowering costs, and expediting treatments.
Discover how the FDA plans to replace animal testing with AI and organ-on-chip technologies for more accurate and ethical drug development.
Establishing bioequivalence for topical drug products can be challenging and costly, often requiring extensive comparative clinical endpoint studies that may not effectively capture formulation differences. However, the FDA’s recent approval…
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