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Featured Product In Submissions and Approvals

Accelerating-Generic-Drug-Development

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

$397.00
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval. Read More

Submissions and Approvals

Jessica Ringel -green600

Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up – Webinar Recording/Transcript

$287.00
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Kristin Zielinksi Duggan Aqua 500

Real-World Evidence in Medical Device Submissions: What Regulatory, Compliance & Quality Professionals Need to Know – Webinar Recording/Transcript

$287.00
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David L. Chesney Aqua 500

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

$287.00
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Eric Henry - green

Medical Device Cybersecurity: Latest Developments – Webinar Recording/Transcript

$287.00
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Lance Shea - green600

Statistics and Data for Regulatory Professionals and Attorneys: Product Performance Evidence Made Easy – Webinar Recording/Transcript

$287.00
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The Biden Webinar

The Biden Administration’s FDA: A Remarkable 2021, What to Expect in 2022 – Webinar Recording/Transcript

$337.00
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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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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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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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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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