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FDAnews offers an Online Books Library Subscription for year-round unrestricted access to all books and reports. They can be accessed, searched, downloaded and read on laptops and other mobile devices anywhere, anytime!

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Managing Data and Documentation for FDA Inspections and Remote Assessments

$225.00
Arm yourself with the knowledge needed to ensure a successful FDA inspection or record review. Order Managing Data and Documentation for FDA Inspections and Remote Assessments today. Read More

Books

ClinicalTrials.gov: Mastering New Reporting Rules

ClinicalTrials.gov: Mastering New Reporting Rules

$397.00
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Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy

Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy

$397.00
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Efficient Premarket Applications: Three FDA Submission Paths That Require Less Time, Money and Effort

Efficient Premarket Applications: Three FDA Submission Paths That Require Less Time, Money and Effort

$397.00
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Equipment Design and Qualification: A Guide for Drug and Device Manufacturers

Equipment Design and Qualification: A Guide for Drug and Device Manufacturers

$397.00
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Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls

$79.00
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Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

$99.00
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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

$129.00
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Biological Risk Evaluation and Management for Medical Devices

Biological Risk Evaluation and Management for Medical Devices

$99.00
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Drugmaker’s Guide to ASTM E2500: Best Practices

Drugmaker’s Guide to ASTM E2500: Best Practices for Increasing Process Efficiency and…

$397.00
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Device Accessories: Understanding and Implementing FDA’s Guidance

Device Accessories: Understanding and Implementing FDA’s Guidance

$177.00
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Hack-Proofing Medical Devices: Ensuring Product Safety through Cybersecurity

Hack-Proofing Medical Devices: Ensuring Product Safety through Cybersecurity

$397.00
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Dealing with China’s Regulatory Authorities

Dealing with China’s Regulatory Authorities: Tips for Devicemakers

$177.00
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