Industry Insights
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A Deep Dive Into Clinical Trial Payment Types, Methods, And Amounts
6/24/2025
Explore key themes surrounding payments to clinical research participants in depth, with a particular focus on the role of participant compensation and best practices in payment logistics.
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The Effects Of Most Favored Nation Drug Pricing On Clinical Trial Management
6/24/2025
Market expert Mathini Ilancheran explains how sponsors can mitigate the effects of "Most Favored Nation" drug pricing while maintaining trial integrity and accelerating time to market.
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Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
6/23/2025
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
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Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs
6/20/2025
The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.
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How Is RIM Software Transforming Regulatory Compliance?
6/20/2025
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
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Why CRA Proficiency Needs A Boost From Better Assessment And Training
6/20/2025
CRAs intend to fulfill clinical research’s commitment to patient safety. Yet, some fall short of true proficiency, and Gerald DeWolfe contends better evaluations and training can help.
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New Data Sources Can Help Pharma Meet Challenges
6/19/2025
Claire Riches, Citeline VP of Clinical Solutions discussed the changing pharma landscape and data options, such as RWD, RWE, and AI at Citeline Elevate Spring 2025.
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EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?
6/19/2025
The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025
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Single Peptides & Pig Testing: How Longhorn's Developing Its Universal Flu Shot
6/19/2025
CEO Jeff Fischer discusses Longhorn's long-acting universal flu vaccine, from its suitability for testing in pigs to overcoming vaccine hesitancy.
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Key Updates To Implementing Regulation (EU) 520/2012
6/18/2025
The evolving pharmaceutical landscape demands continuous regulatory adaptation to safeguard patient safety and ensure compliance, including making updates to reinforce a more centralized, transparent, and technologically aligned EU pharmacovigilance system.