Standards & Regulation

Can digital approaches help improve pharmacovigilance practices?

New ICH guideline revisions are imminent. Sue Batchelor of Cmed shares her thoughts on how sponsors and CROs can prepare themselves.

AppliedVR gets FDA OK to market virtual reality system for chronic pain.

A quick look at reactions across the US to Biden’s Build Back Better bill.

The EMA has given the nod to Ronapreve and Regkirona, two monoclonal antibody treatments for COVID-19.

After a madcap back and forth between leading and dissenting Democrats, Biden’s drug pricing reform plans have reached a compromised final form.

The FDA has approved just three biosimilars in 2021 – but the approvals could shake up the field as discussions around interchangeability intensify.

After nine months of speculation about who will be the next FDA commissioner, we may finally be close to a decision.

We speak with the authors of two studies into extreme increases in US drug pricing, and attempts by lawmakers to bring the price-jackers into line.

Pfizer-BioNTech COVID-19 vaccine receives full FDA approval.