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Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers

December 9, 2021

Over the past four years, the FDA has been signaling increased interest in seeing medical device submissions that rely on RWE. Devicemakers need to know where the agency stands and what it wants to see. This report provides a roadmap to success.

The EU’s New Clinical Trials Regulation: How Sites and Sponsors Can Prepare for the Change

November 3, 2021

This report will outline all the provisions of the regulation, compare them with the current directives and explain the role of the Clinical Trial Information System (CTIS) under the new regulatory scheme.

Compensating Investigators: A Guide for Sites

October 6, 2021

This report answers all your questions about compensating your investigators and guides you through all the decisions and contracting steps, providing examples of how a major research institution sets and budgets for investigator payments.

Data Privacy and Research Transparency: Balancing Opposing Priorities

September 8, 2021

This management report explains in detail what regulators’ research transparency requirements are and discusses how the provisions of the GDPR and other regulations can affect how and what trial data can be disclosed.

Avoiding Inspection Pitfalls: Understanding Common FDA and EMA Observations

September 8, 2021

Avoiding Inspection Pitfalls outlines the most common observations found in inspections, giving examples of where the sites went wrong, explaining how to correct current problems and create processes to prevent future ones, and teaching how to respond to the regulators’ findings.

Digital Health Regulation: Navigating FDA’s Rules for Software as a Medical Device

August 17, 2021

This report explores the FDA’s unique approach to regulating software as a medical device and outlines a method for using automated systems to provide continuous oversight and verification of results.

Perspectives on Clinical Trial Agreements: What Sites, Sponsors and Stakeholders Need

August 17, 2021

Learn how to view clinical trial agreements from all viewpoints to ease negotiations and build a mutually beneficial agreement.

Protecting the Pharma Supply Chain: FDA Efforts at Global Harmonization

July 14, 2021

This report provides the latest information on the FDA’s push for harmonized manufacturing regulations and standards across the globe. The report reviews developments in the U.S., including provisions in recent legislation and executive orders that create new supply chain rules.

Auditing Contractors and Suppliers: A Guide for Drugmakers

July 7, 2021

This comprehensive guide will help you build a GMP auditing program to oversee the quality of incoming goods and services.

Guide to Safety Reporting for Drugmakers: FDA Adverse Event Requirements

June 9, 2021

What, how and when to file adverse event reports is spelled out in a variety of regulations and guidances from the FDA and the International Council on Harmonization (ICH). This collection of 17 regulatory documents provides all the necessary information drugmakers need to report adverse events to the FDA.

Risk-Based Supplier Qualification: Finding the Right Vendors for the Most Critical Supplies

June 9, 2021

In this management report, international quality management expert Christian Gausepohl discusses the life cycle of a supplier relationship, how to determine excipient risks and ways to develop a supplier quality agreement.

Best Practices for Clinical Trial Site Management

May 13, 2021

This collection of in-depth articles from the pages of Research Practitioner, CenterWatch’s bimonthly professional development journal, provides guidance and information on best practices in a variety of areas central to a CRC’s job.

FDAnews Books Library

Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers

The EU’s New Clinical Trials Regulation: How Sites and Sponsors Can Prepare for the Change

Compensating Investigators: A Guide for Sites

Data Privacy and Research Transparency: Balancing Opposing Priorities

Avoiding Inspection Pitfalls: Understanding Common FDA and EMA Observations

Digital Health Regulation: Navigating FDA’s Rules for Software as a Medical Device

Perspectives on Clinical Trial Agreements: What Sites, Sponsors and Stakeholders Need

Protecting the Pharma Supply Chain: FDA Efforts at Global Harmonization

Auditing Contractors and Suppliers: A Guide for Drugmakers

Guide to Safety Reporting for Drugmakers: FDA Adverse Event Requirements

Risk-Based Supplier Qualification: Finding the Right Vendors for the Most Critical Supplies

Best Practices for Clinical Trial Site Management

Upcoming Events

Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

The Inextricable Link Between Data Integrity and Quality Culture

Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

Best Practices for Developing and Maintaining a GxP Training Matrix

FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference?

Featured Products

FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

Selecting and Implementing Electronic Document Management Systems in the EU

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The Revised ICH E8: A Guide to New Clinical Trial Requirements