Regulatory Guidance

Keeping up to speed with the ever-changing global regulatory environment isn’t easy, but it’s vital when it comes to ensuring ongoing compliance. This section offers discussions of new or updated guidance, regulations, and standards.


Anticipating AI regulations in pharma manufacturing

In a rapidly evolving regulatory landscape, leaders should remain ready to adapt to new legislation

FDA year in review: 50 novel drug approvals and more

First-in-class and orphan drugs dominated the agency's 2021 approvals

The fallout from Aduhelm

What our coverage of Biogen’s Alzheimer’s approval got right — and wrong — about the FDA’s decision

Adapting to Brexit in the pharma industry

Exploring the impact of Brexit on UK pharma supply chain

Leave no CMC stone unturned

Building a CMC strategy for biologics is a critical, multistep process

Legal unease

How the generics industry is adjusting as the dust settles on price-fixing lawsuits

Global Dose: Focus on Australia

While the R&D and clinical world has stayed on the cutting edge of modern medicine, the country’s manufacturing industry has slipped through the cracks of Australia’s economy...