Final ICH Guide Supports Nonclinical Development Of Gene Therapy Products
The International Council for Harmonisation has finalized guidance that aims to facilitate the nonclinical and clinical development programs of gene therapy products, while avoiding the unnecessary use of animals.
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Global Medtech Guidance Tracker: May 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-seven documents have been posted on the tracker since its last update.
UK Aims To Quadruple Patient Recruitment To Industry Clinical Trials By 2027
The UK government has set aside dedicated funds to deliver ambitious changes that would make it quicker and easier for companies to trial more of their products in the National Health Service.
EMA To Explain How Trial Transparency & Data Redaction Can Live Together
The European Medicines Agency is working to align the redaction and data anonymization principles underpinning two EU clinical trial transparency initiatives to ensure consistency in disclosure requirements.