Innovation drives speed in early phase drug development. ICON’s Accelerated Pharmaceutical Solutions integrate advanced ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...

In my previous article, I discussed how AI is rapidly transforming the drug discovery process, significantly accelerating timelines and reducing costs. However, while AI's potential in this domain is ...

Clinical trials for drug development are notoriously slow and expensive, and only a small fraction of drug candidates end up being approved by the regulatory authorities. The extensive bottlenecks in ...

Developing a new medication can cost over $1 billion, depending on the drug’s complexity and expenses accrued via unsuccessful studies. Considering these costs, an optimized regulatory process is ...

Accelerated drug development and approval pathways, designed to expedite the delivery of essential medicines for patients with serious and rare diseases, have been successfully implemented in the ...

The development of new medication by biotech and pharmaceutical companies, from target identification to marketing approval, is a time-consuming process with timelines extending to 12 years or more.

Drug discovery has traditionally been slow and expensive, often taking decades and costing manufacturers billions. Traditional methods, while advancing, are hitting limits in tackling the complexities ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

Scientific advice by EMA. At different stages of your development process, you can go for scientific advice with the EMA. While this service is not free, the associated fees can vary, typically ...