Regulatory Blog

This guidance, " Archiving and retention of clinical trial records, "  explains the requirements for archiving and retaining clinical trial records. Proper archiving is essential to ensure that trial data remains accessible, accurate, and verifiable  over time. It supports regulatory compliance and ensures that clinical trials can be reviewed, inspected, or audited when required. Purpose of Archiving and Retention The purpose of this guidance  is to ensure that essential cli

This guidance , " Clinical Trials Regulations enforcement provisions , "  explains how regulatory authorities enforce compliance in clinical trials. Its primary focus is to ensure that trials are conducted in a way that protects participant safety, rights, and data integrity. It supports the implementation of the Medicines for Human Use (Clinical Trials) Regulations, ensuring that all trials meet required legal and ethical standards. Purpose of Enforcement Provisions The purp

Medical devices intended for weight management play an important role in addressing obesity and related health conditions. The U.S. Food and Drug Administration (FDA) has issued guidance to help manufacturers understand regulatory expectations when developing and submitting premarket applications for medical devices with indications associated with weight loss. The FDA guidance titled “ Medical Devices with Indications Associated with Weight Loss: Premarket Considerations ”