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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

$129.00
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

FDA, FTC and DOJ Enforcement of Medical Device Regulations

FDA, FTC and DOJ Enforcement of Medical Device Regulations

$397.00
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Process-and-Design-Validation-for-Devicemakers-2023-500.jpg

Process and Design Validation for Devicemakers: Concepts, Methods and Models

$397.00
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FDA-Pathways-to-Expedited-Drug-Approval-500.jpg

FDA Pathways to Expedited Drug Approval

$397.00
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Auditing to Ensure Manufacturing Quality

Auditing to Ensure Manufacturing Quality: Predicting and Preventing Problems

$397.00
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Medical Device Pathways

Medical Device Pathways: Navigating FDA Roads to Market

$397.00
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International Standards for Clinical Trials

International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

$249.00
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Orphan Drug Designation

Orphan Drug Designation: Benefits and Challenges

$397.00
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Clinical Data Integrity

Clinical Data Integrity: FDA and DOJ Enforcement Priorities

$129.00
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Best Practices in Pharmaceutical Process Validation cover

Best Practices in Pharmaceutical Process Validation

$129.00
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Complying with the EU MDR

Complying with the EU MDR: New Guidances, Standards and Procedures

$129.00
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Navigating FDA’s Proposed Quality Management System Regulation

Navigating FDA’s Proposed Quality Management System Regulation

$249.00
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Recall Readiness: Preparing to Meet FDA Requirements

Recall Readiness: Preparing to Meet FDA Requirements

$397.00
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