Blog
Latest FDA Regulatory Updates: Leadership, Rare Disease Evidence & New Initiatives
Kelsey Lennoch, Associate Director, Regulatory Affairs at Boyds, explores the latest developments and regulatory updates at the FDA and offers guidance for sponsors, clinicians, and scientists navigating this complex environment.
Pilot of medical device clinical investigation fee waiver program for micro and small sized enterprises
The MHRA has launched a pilot program offering clinical investigation application fee waivers to micro and small sized UK enterprises.
20 years of innovation: learnings from the evolution of drug development
Professor Alan Boyd shares insights and key lessons learnt over the past two decades in the drug development industry.
The Regulatory Operations challenge: Avoiding common pitfalls with complex eCTD submissions.
This article highlights the pivotal role and systems that a skilled Regulatory Operations function plays during the often time-constrained phases of a project.
What are the EMA’s latest transparency requirements?
During 2024 and 2025, several important updates to EMA transparency policies have come into effect, notably under the EU Clinical Trials Regulation (EU CTR) and the reactivation of Policy 0070. In our latest blog, Senior Regulatory and Medical Writer, Laura Erwin, explains more.
Updated regulatory guidance for Digital Mental Health Technologies
Eamonn McGowran, Associate Director, Regulatory Affairs at Boyds explains the updated regulatory guidance for Digital Mental Health Technologies.
The FDA CDER/CBER Rare Disease Evidence Principles Approval Process
In a recent communication from the United States Food and Drug Administration’s (US FDA) Rare Disease Innovation Hub1, the general framework of a proposed process for facilitating approval of drugs to treat rare diseases (termed the Rare Disease Evidence Principles, or RDEP) was unveiled.
Understanding the shifting US regulatory landscape: insights for drug developers
Boyds’ Dr Katherine Bowen, Chief Regulatory Affairs Officer and Dr Eric Hardter, Director of Regulatory Affairs, explore some of the key changes and provide advice for drug developers navigating the complexities of the regulatory landscape.