Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing.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

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. Purdue University-led ...

Data integrity is key to the success of any cell therapy program. CDMOs can implement robust data management systems for ...

A federal drug advisory group has begun the cumbersome process of placing fentanyl on the list of drugs to test federal safety-sensitive employees and truck drivers for drug use. While it is clear ...

Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of ...

Pre-employment drug testing can feel overwhelming for many employers. What are the rules? Do certain drugs matter more? What doesn’t matter at all? What can you let slide? The hard part is that ...

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 ...

Researchers have developed a more efficient way to find out which new 'designer drugs' are circulating in the community. In a new study, they showed how high-resolution mass spectrometry can be used ...

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 2026, drug testing remains a critical pillar of workplace safety. However, for organizations operating on Guam, the regulatory landscape represents a unique blend of federal mandates and local ...