Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

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, ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Since President Donald J. Trump took office a second time on Jan. 20, leaders across the biotechnology and pharmaceutical industry have by and large tried to play it safe with the new administration.

Sanford Burnham Prebys is one of several institutions contributing to the federally funded project called PREDICTS ...

The revised EU pharmaceutical policy maintains eight-year data protection but reduces market protection to one year, extendable to three years under certain conditions. Orphan drug exclusivity is ...

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 ...

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 ...

Lucy Xiaolu Wang does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond ...