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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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The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval – Webinar Recording/Transcript
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Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript
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Pharmaceutical Process Validation: Best Practices for Success – Webinar Recording/Transcript
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Gene & Cell Therapy Regulation: Comparability and Other New Developments – Webinar Recording/Transcript
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FDA Ad and Promo Enforcement Trends: Past, Present and Future – Webinar Recording/Transcript
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Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript
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FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions
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