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FDAnews Books Library

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Smart Labeling Self-Audits: Prescriptions for Global Regulatory Compliance

December 9, 2019

There's no doubt: complying with the detailed labeling requirements of every country in which you sell your products is a daunting task. But ... there is one established way to minimize your company's labeling errors and successfully sail through inspections. Setting up your own labeling self-audit programs. And this management report from FDAnews shows you how to do just that.

Regenerative Medicine: Steps to Accelerate Development

December 9, 2019

The Regenerative Medicine Advanced Therapy (RMAT) designation offers applicants an abbreviated pathway to approval, working closely with the FDA throughout the process. This report outlines the RMAT pathway and breaks down requirements regenerative medicine developers must meet to qualify.

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

December 9, 2019

Clinical decision support software … software as a medical device … artificial intelligence and machine learning — rapid developments in digital technology are blurring the line between FDA-regulated medical devices and unregulated "lifestyle apps." This report combs through the guidances and sets out the rules devicemakers must follow.

Regulatory Challenges of Device Acceptance

December 9, 2019

Will your acceptance activities pass an FDA inspection? For device warning letters in 2012, acceptance activities, 820.80, was the fourth most frequently cited QSR section. Don't be among the companies who will be cited this year. Don't risk legal fees, delays and lost time. Get this new FDAnews management report - Regulatory Challenges of Device Acceptance - and help your organization quickly acquire a full understanding of all the relevant FDA regulations.

Risk Management in Clinical Trials: The New ICH E6 Focus

December 9, 2019

When the International Council on Harmonisation (ICH) updated its good clinical practice guidance in 2016, it made major revisions to the section on sponsor responsibilities that emphasize the importance of risk-based thinking. In this report Dr. Susan Leister, Director of Quality Assurance at Technical Resources International, explains the significance of the new focus on risk management.

Process Validation: A Guide for Devicemakers

December 9, 2019

When must a process be validated? That is the first crucial question devicemakers must answer. But with no clear guidance from the CDRH, finding the answer can be difficult. This FDAnews Management report - provides you with the answers. This report will walk you through each point in the decision-making process, including how to determine if a product can be "fully verified," and how FDA inspectors define that term.

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

December 9, 2019

This report explores the draft guidances and other FDA activity on the subject of promotional communication, explaining what companies must do to stay on the right side of the agency's new policies and how to take advantage of the opportunities they present.

QSR-Compliant Purchasing Controls: A Five-Stage Plan

December 9, 2019

The FDAs Quality System Regulation is very clear: you must maintain control of your supplier networks. Follow this five-step plan explains what the regulation requires and how to make sure your system passes muster.

Quality Management Essentials: Expert Advice on Building a Compliant System

December 9, 2019

A strong quality management system is the foundation of a drugmakers success. This collection of essays from five of the drug industrys most knowledgeable practitioners illustrates exactly how to create or update a quality management system that hits all the right notes.

Quality Risk Management for Pharmaceuticals

December 9, 2019

Drugmakers must have an effective quality system. However, a basic quality system that just covers the GMP requirements is no longer good enough. This management report will tell how QRM can be applied both proactively and reactively and explore the potential application of QRM during the different phases of the product lifecycle.

Preparing for the EU GMP Inspection

December 9, 2019

The FDA's GMPs and the EU's GMPs are supposed to be harmonized. Supposed to be. The reality is there are subtle but significant differences between the two. This new handbook from FDAnews tells you what you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections. FDAnews reached out to four authorities on European drug manufacturing quality for their expertise. The result is a handbook you'll refer to whenever the EU inspectors come to call.

Preparing the New Drug Application: Managing Submissions Amid Changing Global Requirements

December 9, 2019

This book will bring you up to speed on recent changes to the NDA process - including the change from paper to electronic format - and guide you step-by-step through the application process. Whether you're an industry veteran or newcomer, this book will help ensure that your new drug does indeed make it to the marketplace.