Featured Pharma Online Editorial
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What FDA Draft Guidance Tells Us About In-Process Control Strategies
2/28/2025
The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.
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Strengthening Shop-Floor QA From The Ground Up
2/24/2025
Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.
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FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products
2/14/2025
The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.
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Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings
2/14/2025
Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.
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GDUFA And Facility Readiness: A New Era for Generic Drug Approvals
2/13/2025
2025 marks the midpoint of the current Generic Drug User Fee Amendments (GDUFA) III program, so it's a good time to refresh yourself with requirements and facility readiness.
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FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program
2/10/2025
The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.
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These Were FDA's Top Citation Issues For Data Quality In 2024
1/31/2025
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.
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2024 Trends In FDA Observations For Sterile Drug Manufacturers
1/30/2025
This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?
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Top 10 Data Auditor Statistical Software Requests
1/27/2025
Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.
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Addressing Blind Spots In Assuring Therapeutic Equivalence
1/14/2025
The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.