Standards & Regulation

Indian CDMO denies manufacturing drug, contract testing lab pulled up for deficiencies, and lessons learned from Sanofi’s warning letter.

In part 2 of our roundtable discussion, thought leaders discuss what Trump could do for drug pricing and whether change is to be feared or embraced.

Biden pushed drug pricing reforms, whereas Trump is known for deregulation. What does this mean for pharma?

The career path of Moncef Slaoui has resulted in billions of doses of lifesaving vaccines. Here he shares his story.

A regulatory science push in the UK includes centres for digital transformation, AI and more.

Robert F Kennedy Jr’s recent speech suggests that investigations into childhood vaccines and over-medication could be on the cards.

The Access to Medicine Foundation has developed the 2026 AMR Benchmark to recognize and promote urgency in the ongoing AMR challenge.

Within two years, pharma companies may be able to rely on technology to automatically create and cross-check entire regulatory submissions.

Stakeholders explain why the NIH’s move to cap indirect costs associated with research grants could damage medical innovation.

US-based pharmaceutical associations fear the supply chain repercussions of tariffs, and offer advice for a more sustainable alternative.