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FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

May 11, 2022
This report, in a question-and-answer format, covers the implications of the shift in the FDA’s inspection model from onsite to remote approaches.

GCP Questions, FDA Answers, 2022 Edition

April 6, 2022
The latest volume in this best-selling series provides answers from the FDA’s Good Clinical Practice Program to a variety of questions related to handling adverse events, investigational product, documentation and storage, investigator responsibilities and more.

Proving Comparability in Cell and Gene Therapy Development: Untangling FDA Requirements

April 6, 2022
Gain a thorough understanding of the FDA’s comparability requirements and how to meet them.

Supply-Chain Solutions: Managing Demand and Logistics in a Postpandemic World

April 6, 2022
Learn about measures drugmakers and suppliers working together can take to ease shortages and keep the industry moving forward during the pandemic and beyond.

Safety Reporting Overload in Clinical Trials: FDA and Site Perspectives on Overreporting of Adverse Events

March 9, 2022
The FDA and trial sites both are struggling under the weight of too many safety reports and both parties are tired of the hassle. This report explains the FDA’s opinion of where the problems lie and outlines what sites can do to reduce the burden.

Best Practices for Clinical Trial Site Management, Vol. 2

March 9, 2022
This report gives readers hands-on guidance for performing a variety of job responsibilities and provides the latest thinking on best practices in those areas.

Measuring Success in Decentralized Trials: Metrics that Drive Improvement

February 9, 2022
This report discusses the challenges and opportunities of using unique metrics to measure the success of decentralized trials (DCT). Using a risk management approach, a metrics analysis plan can be created for DCTs that focuses on potential problem areas and identifies what data are needed to track them.

FDA’s Safety Reporting Requirements: Developing a Compliant Pharmacovigilance Plan

February 9, 2022
Compliance begins with clarification: this report makes clear the requirements for reporting adverse events and other safety issues, it identifies the sources of reportable safety information and the forms/online portals used for FDA reporting, and it simplifies records retention requirements and the agency’s periodic adverse drug event inspections program.

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

February 9, 2022
This report answers the key questions that will enable you to prepare for harmonization: Where does ISO 13485 differ from the QSR and how does the FDA intend to close those gaps? When will this happen? How can you get involved in this effort and make sure your interests are represented?

The MDSAP in 2022: Policies, Procedures and Developments

January 5, 2022
The MDSAP in 2022 provides a comprehensive view of the current state of the MDSAP: its principles and procedures, nations that have joined the program’s original five members and those currently considering joining, policy developments in individual countries, guidance from the FDA and more.

Designing Secure Medical Devices: Building Cybersecurity into the Development Process

January 5, 2022
Designing Secure Medical Devices explains how to incorporate risk and vulnerability assessment into each stage of development, from initial design to validation, testing and implementation, so you stay compliant with FDA’s requirements on cybersecurity.

Selecting and Implementing Electronic Document Management Systems in the EU

December 9, 2021
The drug and device industries are rapidly making the transition from paper record-keeping systems to electronic data management to increase efficiency. But new electronic systems come with many costs, and manufacturers that work in the EU need to know how to select and/or develop systems that best meet their needs. You’ll find all the answers you need in this guide.

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