Accelerated approval process
In such case, the approval of the new drug may be based on data generated in clinical trial where surrogate endpoint shall be considered rather than using standard outcome measures such as survival or disease progression, which are reasonably likely to predict clinical benefit, or a clinical endpoint. These should be measurable earlier than irreversible […]
Regulatory Guidelines for Labelling and Quality Assurance of Medical Devices in India
Introduction: In India, the Central Drugs Standard Control Organization, under the Ministry of Health and Family Welfare, has established comprehensive regulations for the labelling and quality assurance of medical devices. These guidelines aim to ensure the safety, identification, and proper usage of medical devices in the market. The following blog outlines key points from the […]
Regulatory Framework for Clinical Investigations of Medical Devices in India
Introduction: Clinical investigations play a crucial role in the development and evaluation of medical devices, ensuring their safety and efficacy before they reach the market. In India, the regulatory framework for conducting clinical investigations of investigational medical devices is outlined in detailed rules. This blog explores key aspects of these rules, shedding light on the […]
