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Global market access in pharma

Tackling Global Market Access Barriers in Pharma Regulation

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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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FDA Form 483 Warning Letter Inspection Report

How to Effectively Respond to FDA Form 483 and Warning Letters

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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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Key Differences and Market Impact: Generics vs. Biosimilars

Key Differences and Market Impact of Generics and Biosimilars

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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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Project Orbis collaboration for global cancer treatment access and innovation.

Project Orbis: Transforming Global Cancer Treatment Access

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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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ISO IDMP Standards on Data Management for Medicinal Products

The Impact of ISO IDMP Standards on Data Management for Medicinal Products

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The global standardization of information exchange regarding medicinal products is crucial to ensure consistent regulatory compliance, enhance patient safety, and facilitate seamless collaboration across global markets. The ISO IDMP standards help to achieve this by providing a robust framework to ensure identification of products, enhance interoperability between systems, and facilitate clear communication between all key

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Update FDA’s ICH M13A Bioequivalence Guidelines

Key Insights from FDA’s ICH M13A Bioequivalence Guidelines

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Bioequivalence (BE) assessment is pivotal for determining the therapeutic equivalence of generic drug products to their respective reference-listed drugs (comparator products). The BE study should be conducted according to the guidelines set up by the U.S. Food and Drug Administration (FDA). One such guideline “M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms” is a set

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New Points Update of AREE in Latin America

Unlocking New Potential with the AREE Update in Latin America

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In the rapidly evolving pharmaceutical landscape of the world, it is regulatory standards that ensure safe and effective drugs are delivered to patients. In Latin America, Brazil’s ANVISA has slowly been emerging as among the leading authorities of the region to help develop a more robust and globally harmonized framework. It stood out especially with

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Boost Efficiency and Compliance with EDRMS Solutions

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The landscape of pharmaceutical regulatory affairs is developing at a rapid pace in multiple verticals to help enhance efficiency while ensuring strict compliance. This can be relatively daunting highlighting the need for robust systems and tools that can be integrated in daily work to improve operational efficiency. Electronic Document and Records Management Systems (EDRMS) solutions

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Role of AI in Literature Monitoring in Pharmacovigilance

Harnessing AI for Enhanced Literature Monitoring in Pharmacovigilance

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In the rapidly evolving landscape of pharmaceutical safety, integrating Artificial Intelligence (AI) into literature monitoring in pharmacovigilance processes has become necessary. It involves ongoing monitoring and assessment of adverse drug reactions (ADRs), and other potential risks associated with medicinal products. A critical aspect of PV is literature monitoring, which entails reviewing scientific literature, case reports, and

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A Guide to Using FDA’s eSTAR for Medical Device Submissions

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The United States Food and Drug Administration (USFDA) introduced the electronic Submission Template and Resource (eSTAR) program as part of its efforts to modernize and streamline medical device submission. This initiative aims to streamline the 510(k)-submission pathway, which is essential for manufacturers seeking to bring new medical devices. As of Oct 1, 2023, the use

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