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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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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

Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices

Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices

$397.00
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Generic Drug Development: A Guide to FDA Regulation

Generic Drug Development: A Guide to FDA Regulation

$397.00
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Data Integrity in the EU: Requirements for Quality Management Systems

Data Integrity in the EU: Requirements for Quality Management Systems

$397.00
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GCP Qualification Audits: Choosing Quality Contractors and Sites

GCP Qualification Audits: Choosing Quality Contractors and Sites

$397.00
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Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation

Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation

$397.00
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Supplier Assessment Checklists: A Tool for Vetting Vendors and Contractors

Supplier Assessment Checklists: A Tool for Vetting Vendors and Contractors

$197.00
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Informed Consent for Clinical Trials 2017: A Regulatory Reference Guide

Informed Consent for Clinical Trials 2017: A Regulatory Reference Guide

$377.00
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CDRH in Transition: Navigating the New Culture of Quality

CDRH in Transition: Navigating the New Culture of Quality

$397.00
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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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