Standards & Regulation

What did the partial government shutdown mean for the US pharma industry?

Gearing up for 2019, the EMA shares revised guidelines to better protect the environment.

Sitting Down With… Sir Alasdair Breckenridge; Chairman of the Advisory Board, the Centre of Regulatory Excellence of the Government of Singapore...

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.