The rise of messenger RNA (mRNA) technology has transformed the pharmaceutical industry, as shown by its recent creation and use during the COVID-19 pandemic. mRNA therapeutics use synthetic RNA molecules to direct cells to make specific proteins that can prevent or treat illness, unlike conventional drugs that deliver protein directly to the body. mRNA serves […]
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In the dynamic world of pharmaceuticals, biosimilars are reshaping treatment paradigms, offering cost-effective alternatives to biologic therapies while maintaining high-quality standards. The successful development and commercialization of biosimilars hinge on navigating complex regulatory pathways. This guide provides an in-depth look into the regulatory frameworks governing biosimilars in the European Union (EU) and the United States
A Complete Guide to Regulatory Pathways for Biosimilars in the EU and US Read More »
The Asia-Pacific (APAC) region is a rapidly growing hub for pharmaceutical innovation and generic drug development. The increase in demand for generic drugs is due to their low cost and equivalent safety and efficacy to branded drugs. The APAC region incorporates a wide range of regulatory frameworks, from highly developed frameworks of stringent regulatory authorities
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Risk Evaluation and Mitigation Strategies (REMS) is a drug safety program required by the US FDA for certain medicines that are associated with safety concerns. They typically accompany applications to the US FDA, like New Drug Applications, Biologics License Applications, or Abbreviated New Drug Applications (ANDA), that describe drug safety and ensure that the drug’s
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The healthcare landscape of Latin America is evolving with pharmacovigilance taking the spotlight to ensure patient safety and regulatory compliance. While there are many contenders of this region, Mexico standards out as a key player with its proactive approach to adverse event monitoring and international alignment that is shaping the future of drug safety in
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Regenerative medicine is a field that has emerged as a new component of modern medicine/healthcare by introducing therapies that repair or replace damaged tissues and organs through innovative approaches, including stem cells, gene therapy, and extracellular vesicles. Having the potential to address medical needs, regenerative medicine also presents unique regulatory challenges given the lack of
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A pharmaceutical product’s journey through its development lifecycle, all the way to commercialization stage, is relatively complex. What adds more to the complexity is the labyrinth of regulatory requirements, which vary from region to region. Therefore, pharmaceutical companies that want to introduce their innovative therapies face several obstacles as they navigate through the regulatory intricacies
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For companies in regulated industries like pharmaceuticals, biotechnology, and medical devices, regulatory inspections are an integral part of operations. An FDA inspection may feel daunting, but it’s a critical mechanism to ensure compliance with standards (such as Good Manufacturing Practices) to safeguard public health and safety. When compliance gaps are identified, the FDA communicates its
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“Generics” and “biosimilars” are a distinct category of drugs that undergo different development pathways, are subjected to different regulatory requirements and market dynamics. Generic products are copies of small molecule products and are typically developed after the original, or reference product, small-molecule patent expires. Generic products must demonstrate bioequivalence to the reference product and are
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Cancer continues to be a major cause of mortality around the world, highlighting the urgent need for innovative strategies to deliver life-saving treatments to patients. In this pursuit, U.S. Food and Drug Administration (FDA) launched an initiative called Project Orbis in 2019, to transform the global regulatory framework for oncology drugs. Project Orbis has showcased
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