From FDAnews — Adverse Event Compliance in Device and Diagnostics Clinical Trials. Find clear, concise guidelines on adverse event reporting — specifically for device and diagnostics trials. Make sense of all the whats, whens and hows surrounding adverse event reporting. Once an adverse event happens, it’s too late: you have just 10 working days to submit to the IRB and 10 days after that to get results to the FDA. Stay in control, even when unanticipated events happen.

As a clinical trial sponsor negotiating a trial budget, you need to clearly understand what costs are billable to third-party payers, including Medicare, before you sign contracts. Failure to properly address this can result in budget problems, inadequate liability coverage, or even fines and other penalties. Here’s how to avoid Medicare billing problems in your clinical trials: Billing Medicare for Clinical Trials Costs: Avoiding Noncompliance and Budgeting Accurately

Step-by-step, this report helps you master the many aspects of change control and the many regulations that must be factored into emergency decision-making and routine company procedures.

CAPA keeps confounding medical device manufacturers. For two years running, CAPA has spawned more device warning letters than any other regulatory issue. And 2013 is shaping up as just as bad as 2011-12 — or maybe even worse. CAPA’s reporting and recordkeeping demands are major headaches.How does the FDA define ‘well-written report’? How can devicemakers best justify the risk analysis used to support CAPA implementation decisions? How can devicemakers best evaluate CAPA filing systems for FDA   compliance? This new one-of-a-kind report from FDAnews has the answers — and more …

Don't miss out! Successfully sidestep the delayed approvals, lost product batches and plummeting profits that can result from change control failures with this comprehensive report. Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers.

Cleaning Validation: Strategies for Compliance goes beyond the regulations and digs into the real-life world of cleaning validation. Tips to create an effective master plan ... appropriate SOPs ... auditing for compliance ... practical solutions to troublesome cleaning validation challenges ... this timely volume help keep the FDA at bay, boost production efficiency, and fatten your bottom line.

Here's an essential guide for manufacturers seeking FDA approval of groundbreaking new medical products and therapies that combine drug, device or biologic therapies.
Now available as a book/CD-ROM set or individually.

This all-new guide from FDAnews walks you through the steps of managing supplier audits, from initial contract negotiations ... to risk assessment ... to actual conduct of audits ... to documenting and preparing for FDA inspection.

This management report from FDAnews, shows you how to develop a plan to protect yourself from liability and educate your investigators and staff about the importance of upholding confidentiality agreements. Confidentiality in Clinical Trials: Understand Your Liability is a first-line resource to help you learn what the issues are and what you need to do to keep your data secure and your organization safe from unwanted intrusion.

This all-new report from FDAnews walks you through the steps that result in first-class supplier-quality agreements — documents that protect you and your customers from problems.

Specifically geared to devicemakers, discover how to comply with off-label promotion requirements in the management report brought to you by FDAnews — Device Off-Label Promotion: Case Studies to Prepare for Increased Enforcement. This comprehensive report delivers timely how-to tips, off-label case studies, best practices and more that lets you access 10 targeted compliance strategies for off-label promotions, Avoid foot-in-mouth marketing comments, and know the three types of off-label communications that aren’t violative and what actions your staff must avoid in these situations.

This timely document takes you step-by-step through the most complex, challenging process validation compliance problems, filling in the gaps left in the available guidance.

Dietary Supplement cGMPs: Final Rule, the management report from FDAnews quickly zeros in on what the most critical areas of these rules mean to your day-to-day operations — and then delivers expert strategies to help you comply with the latest GMP requirements, specifically tailored to dietary supplement manufacturers, save time with a clear, concise “digest” of the FDA’s 700-page ruling, and know when to use exemptions to the rule and how you can request them.

The EU Clinical Trials Regulatory Reference Guide is the essential manual that gives you an overview of the clinical trial laws and regulations from each of the 27 EU member countries. Before launching clinical trials in EU countries, know exactly what you’re getting into. This guide, painstakingly compiled by the editors of the newsletter Clinical Trials Advisor, reviews the requirements of each of the EU countries and includes web references and complete legislative and regulatory texts where available.

This thorough overview of FDA medical device enforcement trends reveals what triggered 2011 warning letters, and where investigators will be training their sites in the months ahead.