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Regulatory

REMS Logic Model: Framework to link program design with assessment

Blogs, Pharmacovigilance, Regulatory / By

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 / By

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 / By

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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Electronic Submissions for Investigational New Drug Safety Reports

Blogs, Regulatory / By

Regulatory agencies like the United States’ FDA are increasingly encouraging electronic submission of Investigational New Drug (IND) safety reports. Electronic submission has numerous advantages over traditional paper-based submissions such as efficiency, accuracy, accessibility, timeliness and standardization. IND clinical trial sponsors are required to submit the IND safety report of serious and unexpected suspected adverse reactions …

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A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products

Blogs, Regulatory / By

Imagine a world where medical care is not just about treatment but about prediction and prevention. This is what artificial intelligence (AI) in healthcare promises, while also supporting innovation. Regulatory agencies across the globe recognize that AI technology work through a complex series of various processes, highlighting the need for end-to-end management across the lifecycle …

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Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products

Blogs, Clinical Regulatory, Regulatory / By

Advanced therapy medicinal products (ATMPs) including gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options and therefore, have been a subject of considerable interest. Given the increase in …

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Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products

Blogs, Clinical Regulatory, Regulatory / By

Early-phase clinical trials for cell and gene therapy (CGT) products differ from those for other pharmaceuticals due to unique product features and previous clinical experiences, which have revealed substantial risks, including multi-organ failure, leukemia, and tumor development. Factors such as prolonged biological activity, immunogenicity, and invasive administration procedures contribute to these risks. The design of …

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Navigating Orphan Drug Regulations for Gene Therapy Products

Blogs, Regulatory / By

Human gene therapy products, like other medicines, may be eligible for an orphan drug status or designation provided sponsors can demonstrate that the product can treat a rare disease and that they can prove a scientific rationale basis for product’s effectiveness in treating the rare disease. If the eligibility criteria is met, then the orphan …

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Controlled Correspondence for Generic Drug Development

Blogs, Regulatory / By

Regulatory agencies across the globe are committed to ensuring that patients and the public have timely access to safe, effective, and high-quality medicines. They make significant developments, be it revision of guidelines to provide industry with robust support & guidance or expediting review and response times. Recently, the US FDA issued a guidance document for …

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CMC Considerations for Human Gene Therapy INDs

Blogs, Regulatory / By

Human gene therapy represents a groundbreaking frontier in medicinal products for treating complex diseases. This therapy aims to transform gene expressions or modify cellular properties for therapeutic purposes. Regulatory agencies support this innovation by ensuring the required guidelines are in place. For example, the US FDA stands as a guiding beacon for sponsors that wish …

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