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FDA Oversight of Laboratory-Developed Tests — The Impact of the Final Rule
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Learn from a prominent regulatory expert how to optimize your LDT applications to help secure a 510k clearance or premarket approval. Read More
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ICH Q10 Pharmaceutical Quality System — Unpacked and Refreshed – Webinar Recording/Transcript
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Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes, 2024 Edition
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Quality Management Maturity and Measurement for Drugmakers: Expert Insights — An FDAnews Video Presentation
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Quality Culture: From Buzzword to Implementation and Measurement – Webinar Recording/Transcript
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Calculating Sample Size to Satisfy FDA Expectations – Webinar Recording/Transcript
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Reliability Assessment for Medical Devices and Combination Products: Meeting FDA Objectives and Requirements – Webinar Recording/Transcript
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