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Home » Topics » FDAnews Books Library » Files

FDAnews Books Library

 

Gain Access to All Books and Reports

Our Books Library gives you year-round unrestricted access to all our books and reports.

They can be accessed, searched, downloaded and read anywhere, anytime. Topics covered include inspections, auditing, validation, recalls, pharmacovigilance, biosimilars, adverse events, QSR Data, supply chain, financial disclosure requirements and much more. You’ll automatically receive every new book we publish — we'll send you notifications to alert you of each new book in the library.

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Also available: Take advantage of our multi-user and site licenses of the FDAnews Books Library so you’ll have the most-informed workforce! Contact Will Tuttle, Business Development Representative at wtuttle@fdanews.com or +1 612.216.2948 to receive a custom quote.

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FDA Pathways to Expedited Drug Approval

FDA Pathways to Expedited Drug Approval

March 16, 2023
A profile of six major pathways to expedited approval of new drugs plus a deep dive into new legislative reforms that will create a fundamental shift in the Accelerated Approval pathway, bringing more transparency and accountability to the process.
Auditing-to-Ensure-Manufacturing-Quality-500.png

Auditing to Ensure Manufacturing Quality: Predicting and Preventing Problems

March 7, 2023
This report covers the different types of audits and inspections and how to use them to improve quality. It describes the concept of a quality culture, its benefits and role in the company and how to build a quality culture.
Medical Device Pathways

Medical Device Pathways: Navigating FDA Roads to Market

February 7, 2023
This report discusses the FDA’s expectations regarding device risk and the role that risk categories play in determining the precise regulatory approval pathway. It explains the five pathways and how their requirements, benefits and challenges differ.
International Standards for Clinical Trials

International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

January 11, 2023
Developed by regulators and industry groups, the 34 efficacy guidelines in this manual represent the current global view of how clinical trials should be conducted to ensure they are safe and effective.
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Orphan Drug Designation: Benefits and Challenges

December 8, 2022
This management report provides an insider’s view of the program designed to encourage you to research and develop treatments for rare diseases, making the investment of time and resources worth your while.

Clinical Data Integrity: FDA and DOJ Enforcement Priorities

November 17, 2022
With the FDA and Department of Justice (DOJ) getting tougher on clinical data integrity, how confident are you that yours will withstand a thorough examination? This management report features insights and advice from three prominent regulatory and legal experts, two of whom are FDA veterans and all well-versed in both data integrity and the agencies’ priorities in enforcing it.

Best Practices in Pharmaceutical Process Validation

November 17, 2022
Will your SOPs and documentation withstand FDA scrutiny? This management report will help you establish validation procedures that pass muster. By taking a fresh look at the 2011 FDA guidance on process validation and applying it with a full lifecycle approach, you can stay compliant.

Clinical Trials Adverse Event Reporting Guide, 2022

October 5, 2022
This guide incorporates all applicable FDA guidances on reporting adverse events in clinical trials, as well as guidelines from the International Council on Harmonization and the Office of Human Research Protections.

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

September 14, 2022
This report details the factors that are likely to affect MDR compliance and clarifies how they all work together so you can continue your EU operations … no matter how many changes you must consider.

Recall Readiness: Preparing to Meet FDA Requirements

August 3, 2022

This report can help your company better understand what the FDA expects from your recall assessment and implementation, and provide critical advice on how to train and deploy a team that can run recall-related activities smoothly and efficiently.

Navigating FDA’s Proposed Quality Management System Regulation

August 3, 2022
This report outlines the proposed changes to quality systems requirements, explains what they mean and interprets the effect they will have on devicemakers and what action they will have to take.

Risks of Social Media Communication: A Guide to FDA and FTC Enforcement

July 6, 2022
Attorneys deeply engaged in health science regulatory issues and challenges offer practical advice on how companies can use social media to share information about their products without running afoul of FDA or FTC regulations.
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