Regulatory Compliance Archives - Medical Design Sourcing

Navigating the new regulatory terrain pharma companies face with IRA and 340B

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The ever-evolving landscape of pharmaceutical regulations has long been challenging to navigate, but now pharma companies face additional complexities with the introduction of the Inflation Reduction Act (IRA) and the ongoing implementation of the 340B drug pricing program. In recent years, the IRA has made waves for its impact on the pharmaceutical industry, including proposals to allow Medicare to negotiate drug prices for the first time and imposing rebates on drug price increases that outpace inflation. Additionally, the 340B Drug Pricing Program, which was created in 1992, is a U.S. federal government program that aims to allow healthcare organizations to offer affordable prescription drugs to underserved and low-income populations. In 2021, 340B backed entities purchased $43.9 billion worth of covered outpatient drugs under the program.

To get a clearer sense of how the indu…

No room for error: How a holistic quality management strategy can help pharma firms adhere to strict quality standards

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Ever heard the phrase “one bad apple spoils the barrel”? The proverb rings especially true in pharmaceutical manufacturing, where even trace amounts of contaminants can have grave consequences for patient safety. “In the case of pharma, the stakes are so high that even the tiniest contaminants can endanger patients and result in wasted therapeutics, amounting to millions of dollars,” says Dan UpDyke, life sciences strategic marketing manager at Rockwell Automation.

In the following interview, UpDyke explains how a holistic quality management strategy in pharma can help manufacturers adhere to the industry’s strict regulatory standards. Such an approach can help pharma companies avoid problems related to sub-standard ingredients, possible contamination, or a temperature excursion during delivery, all of which can jeopardize the integrity of the entire product.

In the following interview, UpD…

Bridging bioanalytical gaps: Examining validation methods across species

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Bioanalytical method validation is the backbone of effective drug discovery and development. Its pivotal role ensures the generation of reliable and reproducible data from diverse species, leading to safe and effective therapeutics. As critical as this process is, scientists face many challenges, particularly regarding validation across different species in preclinical and clinical studies.

Accommodating species differences requires an understanding of species-specific metabolic and physiologic characteristics. Therefore, customizing a validating method may involve modifying sampling procedures, adjusting analytical parameters, or incorporating species-specific biomarkers. Whether method developers and sponsors do this work in-house or call on a laboratory partner for help, successful validation is when the method consistently delivers accurate and precise results within th…

Driving pharma lab digitalization forward with LIMS

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The digitalization battle in pharmaceutical labs has heated up in recent years. Factors contributing to the trend include mounting pressures of rapid technological evolution, increasing regulatory requirements and a growing demand for efficiency and accuracy in all facets of laboratory operations. A central player in this transformative journey is the laboratory information management system (LIMS), a digital platform designed to manage all the data and processes in a lab, from sample tracking to reporting and quality control.

While LIMS is a game-changer for the pharma industry, with the potential to dramatically increase productivity, reduce errors and ensure compliance with regulatory standards, many labs are lagging in terms of LIMS adoption. The reasons for this are far ranging, including from financial constraints to fear of change and a lack of understanding about the benefits of…