Computer Software Assurance for Production and Quality System Software
CVM GFI #299 -Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication
Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
Quality Management System Information for Certain Premarket Submission Reviews
Menstrual Products – Performance Testing and Labeling Recommendations
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
PRIME: priority medicines
What is the PRIME scheme? The PRIME (Priority Medicines) scheme is a regulatory support programme established by the European Medicines Agency (EMA). It is designed to enhance support for the development of medicines that target an unmet medical need, by providing early and intensified interaction with developers, so that promising therapies can reach patients more […]
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
Why this guidance matters In the evolving world of biologics and biosimilars, precise head-to-head clinical trials are expensive, lengthy and sometimes redundant. The FDA recognises this, and in this draft guidance it offers a refined framework to decide when a Comparative Efficacy Study (CES) is really needed — and when it may be safely omitted. […]