compliance

News

David Hallal, Scholar Rock's chairman and chief executive

Manufacturing issues block FDA nod for Scholar Rock SMA drug

Unresolved issues at a manufacturing plant operated by Novo Nordisk have led to a complete response letter for Scholar Rock's SMA drug apitegromab.

Market Access

neurotech representation of head in code

Neurotech patents in Europe: Methods, medical devices, and t...

The field of neurotechnology is rapidly evolving, bringing together advances in neuroscience, engineering, materials science, and computing.

Digital

person typing on keyboard whilst using surfing a website

Why frictionless digital experiences feel better, and build ...

Digital interactions increasingly shape how we engage with brands, yet the ones that leave the strongest impression often do so by being almost invisible.

R&D

pharmaceutical workforce - a lab with one human worker

When costing and compliance collide

Only a few years ago, compliance was the undisputed top priority in the pharmaceutical industry - regardless of cost.

News

FDA ramps up unannounced inspections of foreign facilities

Trump orders the FDA to ease the commissioning of domestic manufacturing facilities, as the regulator announces more unannounced foreign inspections.

Digital

How to fix pharma's content duplication problem

At the heart of every pharma company lies a big problem: medical affairs and commercial teams are independently creating the same content.