Nearly two years after a new portal was launched for submitting EU clinical trial applications to support the implementation of the Clinical Trials Regulation (CTR), the focus is now on simplifying compliance with one of the most complex aspects of the legislation – its transparency provisions.
Navigating The EU's Revised Clinical Trial Disclosure Rules
Interim Measures Provide Options For Early Adoption Of The Updated Requirements
The European Medicines Agency is preparing to roll out simplified transparency rules for its Clinical Trials Information System in mid-2024. This article looks at what will change and the impact on the thousands of trials that are already in the system.
More from Pink Sheet Perspectives
More from Pink Sheet
• By
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
• By
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
• By
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.