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Regulatory

Regulatory Framework for Software and Artificial Intelligence as Medical Device

Blogs, Medical Device, Regulatory /

The convergence of healthcare with technology has led to giant innovations, one of the most significant being the use of software and artificial intelligence (AI) as medical devices. Such developments have been called Software as a Medical Device (SaMD) by many and have wide applicability in transforming the diagnosis, treatment, and care of patients medically. […]

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Specifications for In Vitro Diagnostic Devices

Blogs, Medical Device, Regulatory /

In vitro diagnostic medical devices (IVD devices) are an integral part of the healthcare system. They are typically used to analyze samples that are collected from the human body (i.e., saliva, blood, tissue, and urine) and help in diagnosing, screening, and monitoring various conditions. IVD devices are subjected to different regulations that specify different requirements

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The Use of EDDO to Ensure Drug Delivery Function

Blogs, Medical Device, Regulatory /

When it comes to ensuring the safety and effectiveness of medical devices intended to deliver drugs, understanding Essential Drug Delivery Outputs (EDDOs) is important. The advent of drug-device combination products has necessitated the development of robust guidelines to ensure safety, efficacy, and performance. One such crucial aspect of these combination products is the Essential Drug

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Clinical Evaluation of Orphan Medical Devices

Blogs, Clinical Regulatory, Medical Device, Regulatory /

In the European Union, the Medical Device Coordination Group (MDCG) continues to address unique challenges in the medical field, by bringing life-changing orphan medical devices to patients who suffer from rare conditions. These devices that are intended for a small number of individuals are subject to various hurdles in their development and market introduction. The

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Recommendations for the use of Animal & Human Derived Materials in Cell and Gene Therapy Products

Blogs, Clinical Regulatory, Regulatory /

The number of cell and gene therapies coming into the market each year is increasing steadily. An article published by McKinsey and Company in 2022 expected as many as 21 cell therapy and 31 gene therapy launches in 2024 itself. The growing focus on cell and gene therapies (CGT) presents a unique set of challenges to

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Accelerating Product Registration with SFDA’s Priority Review

Blogs, Regulatory /

It is important for regulatory agencies to implement priority review processes in order to expedite drug approval processes. This ensures fast access to safe innovative treatments and life-saving medicines. By streamlining drug review processes that address unmet medical needs, or offer better treatment options compared to existing therapies, these processes can accelerate patient access. This

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REMS Logic Model: Framework to link program design with assessment

Blogs, Pharmacovigilance, Regulatory /

Risk Evaluation and Mitigation Strategies (REMS) helps the FDA in ensuring that the benefits of a drug outweigh its risks. These strategies are particularly important for medications with significant safety concerns and require a well-structured approach to both design and assessment. The FDA’s guidance on the Risk Evaluation and Mitigation Strategy (REMS) logic model presents

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Enhancing Global Drug Development through ICH M11

Blogs, Clinical Regulatory, Regulatory /

The development of new drugs is a complex process involving clinical trials conducted across multiple countries. This can lead to challenges due to differing regulatory requirements and variations in how clinical trial protocols are formatted. The International Council for Harmonization (ICH) M11 Protocol Template, based on the ICH M11 guideline, aims to address this by

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Data Integrity for In Vivo BABE Studies

Blogs, Regulatory /

The pharmaceutical industry is evolving with technological advancements with a subsequent increase in regulatory scrutiny that emphasizes maintaining the accuracy, completeness, and reliability of data- it has become more critical than ever. Data integrity ensures that information is trustworthy, verifiable, and compliant with regulatory standards. It is essential for safeguarding patient well-being, supporting regulatory approvals,

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