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By Marcelo Trevino, independent expert | The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. | |
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By John W.M. Claud, Nelson Mullins Riley & Scarborough | FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question. | |
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By Andrey Meshcheryakov, Recombinators | Software is no longer just a support tool; it is central to real-world efficacy, transforming combination products by optimizing dosing, adherence, and technique. | |
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| USP <788> Revisions And Why Packaging Matters More Than Ever | Article | By Victoria Morgan, West Pharmaceutical Services, Inc. | Prepare for the upcoming USP <788> revisions by strengthening your particulate control strategy to support regulatory compliance, product quality, and patient safety across injectable drug products. |
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| The Evolution Of Structural Heart Innovations | Article | Secant Group & Polyzen, part of the Solesis family of companies | Structural heart innovation demands thinner, stronger materials and scalable manufacturing. Read how material expertise and customization are overcoming industry challenges for better patient outcomes. |
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