DDReg pharma

Quailty Driven by Passion

Submit Query

Blogs

Home » Blogs » Page 14

Data Integrity for In Vivo BABE Studies

All Category, Blogs /

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, […]

Data Integrity for In Vivo BABE Studies Read More »

Electronic Submissions for Investigational New Drug Safety Reports

All Category, Blogs /

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

Electronic Submissions for Investigational New Drug Safety Reports Read More »

A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products

All Category, Blogs /

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

A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products Read More »

Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products

All Category, Blogs /

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

Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products Read More »

Pharmacovigilance in New Zealand

All Category, Blogs, Pharmacovigilance /

Medsafe oversees pharmaceutical product regulation in New Zealand and operates under the Medicines Act 1981 which mandates sponsors to report substantial untoward effects of their medicines. The requirement for regulations are highlighted in the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) which also has a Pharmacovigilance (PV) guidance document. This provides

Pharmacovigilance in New Zealand Read More »

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

All Category, Blogs /

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

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

Navigating Orphan Drug Regulations for Gene Therapy Products

All Category, Blogs /

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

Navigating Orphan Drug Regulations for Gene Therapy Products Read More »

Conducting Clinical Trials for Investigational Products in Brazil

All Category, Blogs /

Brazil is emerging as an attractive location for clinical research as it offers access to a range of patient demographics and medical facilities due to its diverse population and robust healthcare infrastructure. Conducting clinical trials for investigational products is a meticulous and highly regulated process, requiring sponsors to adhere to stringent guidelines. This ensures the

Conducting Clinical Trials for Investigational Products in Brazil Read More »

Controlled Correspondence for Generic Drug Development

All Category, Blogs /

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

Controlled Correspondence for Generic Drug Development Read More »

CMC Considerations for Human Gene Therapy INDs

All Category, Blogs /

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

CMC Considerations for Human Gene Therapy INDs Read More »