There’s no doubt that these new requirements will increase the regulatory burden on drug and biologics trial sponsors and investigators already laboring under a heavy load. That’s why the new special report Adverse Event Reporting for Drug and Biologics Trials is essential for busy executives involved in clinical trials and regulatory affairs.

Produced by the British Pharmacopoeia Commission Secretariat, the British Pharmacopoeia 2013 is the leading collection of standards for UK medicinal products and pharmaceutical substances.

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.

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 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.

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.

Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus. In addition to warning letters, the agency is filing lawsuits and even seizing product. What’s a supplement manufacturer to do? Get up to speed — fast. Take an FDA crash course. How do inspections work? What does the agency expect in document compliance? Which GMP mistakes are most likely to be targeted? Luckily, help is now at hand.

Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.

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.

Place your order today for this management report from FDAnews — FDA Advertising and Marketing Enforcement Update: What a Newly Reenergized DDMAC Means to You. Essential reading for all marketing and regulatory affairs professionals — and for key members of your promotional materials review team — this three‑in‑one management report gives you fingertip-access to the latest DDMAC enforcement trends, an anytime “refresher course” on the basics of DDMAC compliance, and protection against future warning letters with a special “enforcement trend forecast” for 2009!

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.