Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing. The ...

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...

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 ...

Harnessing a pervasive type of cellular messenger shows early experimental promise as a routine way of sampling and monitoring the body's response to prescription drug exposure. Experiments have ...

Drugs have been tested on animals for over a century, but new technology may one day eliminate the need to do so. Congress and the FDA are pushing pharmaceutical companies to replace animals with ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...