Standards & Regulation

Oscars of science, drug shortage reporting requirements, and a new gene therapy... What’s new for pharma in business?

The FDA’s Janet Woodcock explains how manufacturing will change in the coming years.

Analytical bioassay cell banks certainly have benefits. But it can be difficult to know what best practices to follow.

The PRGLAC Task Force hopes to change the landscape for research on pregnant and lactating women.

Including pregnant women in research isn’t as difficult as some might think…

One pharma company is working to pioneer safer drugs for use during pregnancy…

The lack of evidence available from pharma companies to guide care of pregnant women is ethically unacceptable.

Is pharma putting women and children last?

A recent review and meta-analysis highlights the huge impact of fake and substandard drugs.

“Right to Try” legislation may have compassion at its heart, but it does not do enough to ensure patient protection.