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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!

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

CRF Vol 3 2019

Three-Volume Clinical Trials Title 21 CFR Set 2019

$210.00
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CRF 5 2019

Five-Volume Drugs/Biologics Title 21 CFR Set 2019

$300.00
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CRF 9 2019

Nine-Volume Title 21 CFR Set 2019

$585.00
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The-EU-MDR-Transition

The EU-MDR Transition: Meeting the CE Mark Deadline

$397.00
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EU-Compliant Batch

EU-Compliant Batch Release of Medicinal Products: How to Meet the Requirements of Annex 16 of the EU…

$135.00
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IOM-IMAGECOVER

Investigations Operations Manual 2019

$377.00
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Accelerating-Generic-Drug-Development

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

$397.00
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Surviving the New FDA Inspection Plan

Surviving the New FDA Inspection Plan: A Drugmaker’s Guide to Working with the Agency

$497.00
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The 21st Century Take on Observational Studies

The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium

$397.00
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Device Software Development: A Guide to Risk Management Requirements

Device Software Development: A Guide to Risk Management Requirements

$397.00
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Regulating Digital Health Tools

Regulating Digital Health Tools: Understanding the FDA’s New Guidances

$397.00
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Surviving an MDSAP Inspection: A Guide for Devicemakers

Surviving an MDSAP Inspection: A Guide for Devicemakers

$397.00
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