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Featured Product In Books

FDA’s Alternative Inspection Tools

FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

$397.00
If you want to pass your next inspection, FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions is a must. Read More

Books

Kristin Davenport, Rujul Desai and Christina Kuhn-red600

Medical Device Premarket Review Pathways and FDA Mechanisms for Expedited Review – Webinar Recording/Transcript

$287.00
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Susan M. Proulx

Pharmaceutical Naming Regulation: Understanding the Latest Developments – Webinar Recording/Transcript

$287.00
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Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers

Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers

$397.00
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Susan Lee and Elizabeth Mulkey - 500aqua

Promoting & Marketing in the Digital and Virtual World – Webinar Recording/Transcript

$287.00
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New Inspection Models

New Inspection Models: Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid?

$397.00
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Beth Packman Weinman - Blue 500

Drug Safety Reporting Requirements: Best Practices for Monitoring, Reporting and Avoiding Regulatory Missteps – Webinar Recording/Transcript

$287.00
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Special Pathways for Innovative Devices

Special Pathways for Innovative Devices: A Guide to the FDA’s Breakthrough Device and Safer Technologies Programs

$397.00
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Kevin Wells - red 600

Extractables and Leachables: Taking a Deeper Dive – Webinar Recording/Transcript

$287.00
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DAVID L. CHESNEY, MSJ, green600

Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript

$287.00
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Jim Polarine - aqua500

Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19 – Webinar Recording/Transcript

$287.00
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Kristin Zielinksi Duggan -blue500

Real-World Evidence in Medical Device Submissions – Webinar Recording/Transcript

$287.00
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Digital Health Regulation

Digital Health Regulation: Navigating FDA’s Rules for Software as a Medical Device

$397.00
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