Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...

The biggest challenge in drug development is that the process is not an even balance of hit or miss – it is overwhelmingly miss, with around 90% of drugs never making it beyond clinical trials. As a ...

Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...

There’s no doubt that large language models and generative AI tools have taken the world by storm. Their ability to create, ...

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors, and the general public. Researchers have ...

Leveraging its integrated "design-synthesis-quality control" system, Creative Biolabs is overcoming bottlenecks in mRNA ...

Khoshsokhan, Sina. The Costs They Are a-Rising: Commercialization Costs and the Innovation Process in Drug Development. Academy of Management Annual Meeting Proceedings. 2024, Vol. 2024 Issue 1, p1-6.

A key part of consultants’ work is the global harmonization of CMC guidelines. Differences in regulatory requirements across regions can lead to inefficiencies in the drug development process.