Featured Pharma Online Editorial
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What Did ICH Q14 Miss On Analytical Method Validation?
7/7/2025
Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.
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Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices
7/3/2025
Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.
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Understanding FDA's New National Priority Voucher Pilot Program
6/25/2025
The FDA's vouchers will be issued to companies addressing health issues in the U.S. and increasing domestic manufacturing, among other criteria.
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AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence
6/23/2025
Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management.
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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Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs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The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.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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A Look At Elsa, The FDA's New AI Digital Assistant
6/12/2025
The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.
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Navigating Data Management Requirements For Sterile Manufacturing
6/11/2025
Contamination control strategies are rooted in representative and trustworthy data, but companies still do a poor job at maximizing their use of data to optimize.
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Bracing For The Impact Of The Federal Workforce Reduction
6/9/2025
The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.