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Summary Notes On DTAB (Drug Technical Advisory Board), P1988 FDC’s (Fixed Dose Combinations)

Posted by: Jitendar Chauhan April 17, 2023

Drug Technical Advisory Board (DTAB): The Drug

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17th April, 2023

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Regulation/Guidelines

Regulatory Challenges of SaMD: Navigating Global Standards and Compliance

Overview Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications. Challenges include managing risks, demonstrating clinical evidence, and ensuring data security. Harmonisation efforts and...

4th November, 2024

Regulation/Guidelines

The Future of SaMD: Emerging Trends and Innovations

Overview The future of (SaMD) Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring. Emerging trends emphasise real-time data integration, stronger regulatory...

4th November, 2024

Regulation/Guidelines

Understanding SaMD: What Makes Software a Medical Device?

Overview Software as a Medical Device refers to software applications designed for medical purposes, such as diagnosis, treatment, or monitoring, without being part of a physical device. Software as a...

4th November, 2024

Regulation/Guidelines

Quality Management Systems for SaMD: Best Practices and Standards

Overview Quality Management Systems for SaMD requires compliance with regulatory standards, implementation of robust quality management systems, and risk management through design controls, testing, and post-market surveillance. It also involves...

22nd October, 2024

Drugs and Cosmetic Act

Drugs and Cosmetic Act

Summary Notes On DTAB (Drug Technical Advisory Board), P1988 FDC’s (Fixed Dose Combinations)

For Importers To India

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