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The Revised Common Rule: New Requirements for Clinical Trials

December 9, 2019

Two prominent healthcare attorneys sift through the new rule to mark out every deletion highlight every addition interpret every rewording that clinical research professionals and institutions will need to understand to be compliant.

Tools for Faster Drug and Device Development: FDA's New Pathways to Innovation

December 9, 2019

This comprehensive collection of FDA guidances and policies on drug and device development tools features a preface by noted FDA law expert Jim O'Reilly laying out the current landscape of drug and device development tool research. He explains how the 21st Century Cures Act has established an updated, multi-stage process for development tool qualification and explores how the FDA will implement it.

Top Ten Data Integrity Traps: How to Find and Fix Problems

December 9, 2019

Virtually every area of your operations impacts the integrity of your data. If you want to lock down your systems to make sure data errors cant creep in, you need to identify the common and often critical gaps that can lead to serious data integrity problems.

The Drug Manufacturer's Guide to Site Master Files

December 9, 2019

Beginning in January of this year, all European inspectors began asking for a site master file that complies with the 2011 PIC/S revisions to GMPs. If you Don't have an updated site master file - or a site master file at all - you're out of compliance with dozens of new or changed requirements. This management report from FDAnews will help you perform a comprehensive gap analysis that assures your Site Master File matches your company's activities.

The FDA's New Inspection Practices: A Guide for Drugmakers

December 9, 2019

Your next inspection will not be like your last one! This management report explains the FDAs plans for upgrading its inspectorate and provides the key resources you will need to prepare for your next inspection.

The Impact of Off-Label Promotion on Product Liability

December 9, 2019

Your product is not approved for a particular use. You promote that product off-label, perpetuating the non-approved use. If patients are injured and become plaintiffs they could then argue that you failed to warn about the dangers associated with that particular use of the product. From a product liability standpoint, it will be nearly impossible for you to disclaim responsibility for warning about an off-label use. Here's the report that shows you how to minimize this risk.

Surviving an MDSAP Inspection: A Guide for Devicemakers

December 9, 2019

The Medical Device Single Audit Program MDSAP is now being implemented by five countries with EU participation possibly in the offing. If you pass one MDSAP inspection youll be ready to pursue marketing authorization in five separate countries. The prescriptive nature of the MDSAP model makes it relatively easy to prepare for an audit if you know what to expect.

Surviving the New FDA Inspection Plan: A Drugmakers Guide to Working with the Agency

December 9, 2019

CDERs new plan for assessing the quality of a drug is with a team approach. The guide explains the agencys integrated approach and how you can make the most of the FDAs quality priorities and inspection procedures.

Taming the Change Control Beast: Creating and Maintaining Effective Change-Control Forms

December 9, 2019

Each company must maintain a state of control for any process used to manufacture regulated product. Showing the FDA that you do the same thing the same way every time keeps you on the agency's good side. Most companies rely on change control forms to track changes and describe current states of control. This management report is indispensable for anyone involved in producing or maintaining these crucial documents.

The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium

December 9, 2019

The report walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. It looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products.

The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium - 2018

December 9, 2019

Since the 21st Century Cures Act opened the door for observational studies to join traditional clinical research in the drug and device approval process, many companies are taking the first steps into the use of real-world evidence. This new edition presents new information on the encouraging results those pioneers have found.

Strategies for Risk-Based Clinical Trial Monitoring and Inspections

December 9, 2019

You're probably on the fence about employing a risk-based clinical trial monitoring program. Many are, preferring the old methods of 100 percent verification of data - and intense site visits - that they're more familiar with. But the fact is risk-based monitoring with a centralized data monitoring component can actually produce better levels of compliance than the old ways - if it's done correctly. This FDAnews management report will show you exactly what 'done correctly' is.