A New Era for Rare Disease Innovation in the UK?

The MHRA’s Proposed Rare Disease Therapies Regulatory Framework: A New Era for Rare Disease Innovation in the UK? The UK Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation this spring on its proposed Draft rare disease therapies regulatory framework, signalling one of the most significant potential reforms to the regulation of rare […]

A fresh look for Fusion: our new website is here

Despite having no previous experience of updating websites, I somehow found myself volunteering to take on the Fusion website refresh. I then discovered a surprising number of other extremely urgent jobs whenever “review website” appeared in my calendar… Eventually, I realised this was getting me nowhere, so I blocked out a chunk of time, opened […]

InFusion Mentoring

You’re the person people turn to – but who do you turn to? In Regulatory Affairs, we spend a lot of time answering other people’s questions. Can we submit this? What does the guidance mean? What is the risk? Is there another way forward? But sometimes we need someone to help us work through our […]

Scientific Advice or Pre-submission Support?

Scientific Advice or Pre-submission Support? Understanding the MHRA’s Evolving Approach to Early Engagement If you’ve worked with the MHRA in recent years, you have probably noticed that the path to regulator interaction has become more structured. The introduction of updated Scientific Advice requirements and an expanded pre-submission support framework provide greater clarity in how the […]