Understanding and Implementing a Risk-Based Approach to 21 CFR Part 11 Compliance

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

This episode is a compilation of comments taken from a series of interviews where experts are discussing how AI might impact the global bio/pharma industry in the future.

CNP-104 is a biodegradable nanoparticle that previously received fast track designation from FDA in January 2022, which would eventually make it eligible for accelerated approval and priority review.

In this podcast episode, we discuss trends in dosage forms, specifically oral solid dosage, as viewed by five industry experts who recently exhibited at CPHI Milan.

The AI Lab was launched almost exactly three years ago and has produced several programs so far, at least one of which achieved its first scientific stage gate 40% faster than the teams originally forecasted.

Using splicing technology, the new company aims to innovate safer and more effective RNA therapies for severe genetic diseases.