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Regulatory

ICH: An Approach to Harmonizing Real World Data & Real World Evidence

Blogs, Regulatory /

The use of real-world data (RWD) and real-world evidence (RWE) in Life Sciences and Pharma is significantly gaining recognition for the value it brings in making enhanced regulatory decisions. The evaluation of pharmaceuticals throughout their development and lifecycle is a complex process that requires robust evidence to ensure their safety and effectiveness. Traditionally, randomized clinical […]

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US FDA: Resolving Disputes for Over-the-Counter Monograph Drugs

Blogs, Pharmacovigilance, Regulatory /

Over-The-Counter (OTC) monographs define the safety, effectiveness, and labelling of the active ingredients in OTCs. The US FDA released a guidance document that provides suggestions for industry and review staff on resolving scientific and medical disputes related to OTC monograph drugs. It describes the Center for Drug Evaluation and Research (CDER) formal dispute resolution (FDR)

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US FDA: Safety Reporting Requirements for Combination Products

Blogs, Pharmacovigilance, Regulatory /

In this new era, where different therapeutic realms converge, the emergence of combination products has revolutionized the healthcare landscape by providing more innovative treatment options to treat the unmet medical needs of patients. However, with great power comes great responsibility. Continuously monitoring these products and ensuring they are safe to use is paramount in order

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Challenges in Complex Generic Drug Development

Blogs, Pharmacovigilance, Regulatory /

Complex drugs add more value to patients compared to simple generics as they are capable of addressing unmet needs of patients for particular conditions. However, biopharmaceutical companies encounter distinctive hurdles when it comes to the advancement of complex generic drugs. These medications, known for their intricate characteristics or the requirement of additional clinical trials, necessitate

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US FDA: Keeping Up with the Momentum of Decentralized Clinical Trials

Blogs, Pharmacovigilance, Regulatory /

Decentralized clinical trials (DCTs) are evolving and gaining momentum within medical research as they increasingly incorporate state-of-the-art digital health technologies (DHTs). Indeed by way of DHTs, useful data for clinical trials can be collected, exchanged, transferred, and stored electronically and in a more efficient manner. In order to stay aligned with the momentum, regulatory agencies

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Innovative Medicines

Evaluating PRIME: A Pathway for Innovative Medicines

Blogs, Regulatory /

In various therapeutic areas where life expectancy is low, delayed market access to effective medicines has highlighted the need for expedited responses by regulators to support timely access to such priority medicines. The Priority Medicines Scheme, or PRIME, was implemented by the European Medicines Agency (EMA) to support and accelerate medicine development that targets unmet

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Clinical Practice

Enhancing Good Clinical Practice for the Evolving Clinical Trial Landscape

Blogs, Pharmacovigilance, Regulatory /

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft guideline update- the ICH E6 (R3)- that focuses on the application of Good Clinical Practice (GCP) to new trial designs, technological advancements, and enhancing a risk-based approach in clinical trials.The ICH E6 (R3) serves as an update to

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FDA Compliance

How do Artwork Management Systems help maintain FDA compliance?

Artwork Management Services, Blogs, Regulatory /

The pharmaceutical industry is a highly regulated environment where investing in a reliable and efficient method for managing artwork can result in significant cost savings. Artwork management forms an integral part of regulatory affairs. The main objective of an artwork management system is to ultimately prevent product recall. Pharmaceutical companies invest significant time, money, and

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Drug Device Products

Drug-Device Products: Navigating through the EU

Blogs, Medical Device, Regulatory /

Drug-device combination (DDC) products are increasingly demonstrating the value they bring in diagnosing, treating, and curing complex diseases. The growth of the DDC market is driven by several factors including an increase in chronic diseases, a well-established medical technology industry, a rise in surgical procedures, the availability of funding for research and innovation etc. As

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Digital Health Technology

Indian Perspective on Digital Health Technology

Blogs, Regulatory /

Digital health technology has gained significant momentum in India, revolutionizing healthcare delivery and improving accessibility and efficiency. It acts as a fundamental support for providing value-based care throughout the healthcare system. Various digital health technologies, including telemedicine and health monitoring apps, are transforming the healthcare landscape in India.The Indian Prime Minister introduced the National Digital

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