This indispensable management report maps out a comprehensive strategy for recall planning. From creating a recall committee to handling communication and policy changes during a recall, you'll be at work with today's best practices for containing damage and keeping your edge.

From infectious diseases to cancer tests, the point of care (POC) diagnostics market was worth a hefty $13.7 billion in 2010. What will it be worth by 2016?  Which sectors will soar or stagnate? How will regulatory and clinical drivers affect growth?

Preparation and Maintenance of the IND Application in eCTD Format. Whether you’re still filing IND submissions in paper, or have filed electronically for a while, you’ll value this just-published book from FDAnews. Author William Sietsema, drawing on his real-world experience with IND submissions — and adding real-world case studies from ZymoGenetics and Epix — offers ready-to-use, expert guidance on the content and structure of all the components of an IND in CTD format with the focus on electronic submissions.

Brought to you by FDAnews, Prepare for Increased Enforcement of Off-Label Promotion Regulations is a management report that delivers solid strategies to keep you in compliance with off-label promotion laws. Stay off the FDA’s “hit list” for good, and avoid millions of dollars in criminal and civil fines.

This new report from FDAnews takes you step by step through how to prepare for and how to conduct yourself during — and after — the critical preapproval inspection.

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.

Whether you’re new to the quality profession or you’re a veteran looking to strengthen CAPA processes in today’s tougher enforcement climate, Principles of an Effective CAPA System: A Guide for Device and Drug Companies plugs you into best practices that help you avoid the investigation, documentation and corrective action mistakes that have landed so many other companies with warning letters.

Discover step-by-step how you can profit from shorter cycle times, greater product availability, higher yields and more — when you put PAT tools to work at key phases of your manufacturing process. You'll even jump the learning curve with eight dos and don'ts of a successful PAT program.

Since 2009, warning letter citations make clear that it’s no longer enough for you to look back at the data and then react to quality problems. You are now expected to trend your quality data.

Quality of Life Claims, Marketing and the FDA: Creating a Competitive Advantage in a Crowded Market, the management report from Value of Insight (VOI) Consulting, Inc. and FDAnews maps out what’s required to pass muster with CDER and DDMAC — and how to avoid extra trial costs by building in QoL data-gathering right from the start. By combining exclusive surveys with real-world guidance, Quality of Life Claims, Marketing and the FDA helps you zero in on your own best strategy. Plus, you’ll learn how companies have used QoL claims and marketing to turn pipelines from lackluster to blockbuster.

The FDA originally videotaped these 10 training sessions — more than eight hours’ worth — to train its own staff in quality training. Now FDAnews has brought all 10 sessions together on one convenient, affordable DVD, designed to give you the kind of high-level employee education everyone wants … with the flexibility that makes in-house training most beneficial.

Recruitment and Retention in Clinical Trials: What Works, What Doesn’t and Why shows you how to trade outdated strategies for clinical trial retention and recruitment solutions that get your therapies to market faster — and for less.  This one source connects you with today’s most innovative, effective tools and tactics. From turning physicians into powerful allies, to simple education strategies that can boost recruitment 50 percent, you’ll discover how to win participation from a wider pool of subjects and keep them on board.

Congress has started pushing both the FDA and NIH to begin penalizing drug sponsors who do not report on ClinicalTrials.gov. New legislation is also pending in the House of Representatives to increase reporting requirements and also step up penalties.

To date, the FDA has approved more than 100 Risk Evaluation and Mitigation Strategies (REMS) plans ranging from simple medication guides to complex, multi-part programs. Now drugmakers can take advantage of the lessons learned from these early, successful REMS — and avoid substantial delays and serious problems that might arise while satisfying FDA requirements about product safety.

Reportedly Trained or Truly Trained: Developing GMP Training that Works, this unique report from FDAnews details what your training program must include to be effective including two areas that should become your training focus and will yield a return on investment, four root causes of inadequate training, three domains of educational activity, four ways that adult learners effectively perceive information, and the six levels of learning and how to determine which level is appropriate for specific tasks.