The FDA leaves it to you to determine supplier risk and reliability, via audits that you conduct. But make a wrong call and you could face a Form 483, a warning letter or, even worse, liability lawsuits. So here’s the question of the day: Are you doing your best job on audits? If the answer is no … or even maybe … get timely help from FDAnews.

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.

The new EU pharmacovigilance directive takes effect July 12. If you don’t think you can meet that deadline ... if you have even the slightest doubt ... please read the rest of this letter now.

False data in clinical trials isn’t new. What is new is the aggressive role the FDA expects drug and device companies and CROs to play. Under a proposed rule, the FDA says clinical trial sponsors must be proactive in reporting data that is even possibly false. But while it’s clear that noncompliant sponsors will face harsh prosecution, it’s less clear exactly what to report, how … and when.

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.

What are the five hottest areas of concern showing up in FDA warning letters? How are the agency’s changing priorities impacting its enforcement trends? And what can you do to avoid common pitfalls cited in the FDA’s most recent Warning Letters? The answers are no mystery. They appear in this standout new management report from FDAnews.

The most complex corrective and preventive action (CAPA) issues are often found outside the routine channels you may already be using to assess and track CAPAs. Make sure you take all the issues into account based on industry guidances — and uncover tough-to-spot problems, before they trigger an FDA warning letter.

Clinical trials operators — the FDA is drawing a bead on you. Since 2008, the agency has issued 52 warning letters to investigators, CROs, sponsors and IRBs — an astonishing 30% increase over previous levels.

This management report is designed to address your specific concerns about PREDICT and the new FDA import processes — and show you how to prepare to successfully get your imported products through customs as quickly as possible.

FDA Pharma Manufacturing Essentials brings together tested and practical advice that tackles the most pressing issues a pharma executive faces ... all in one, high-level and comprehensive resource.

Now available from FDAnews, this information-packed management report maps out exactly what the new joint inspections mean to your facility — and what you must do now to prepare. Step by step, you’ll learn how to troubleshoot potential problems and align GMPs with both FDA and international rules.

To a new employee — and even some veterans — the FDA is a mystery: Part cop, part scientist and part politician. But it’s the most important agency you, as a newcomer to the industry, will ever deal with. Wouldn’t it be a good idea to know how the agency really works?

In medical device manufacturing, success means staying abreast of regulatory changes from Argentina to the United Kingdom ... and beyond. Impossible? Not at all.

International compliance is no longer simply a matter of playing by the same old rules. There’s been a dramatic increase in foreign inspections. Many countries are collaborating via joint inspections and confidentiality agreements that permit sharing of inspection results. And in many countries, drug safety concerns are prompting new requirements. You learn the new rules of the game, or cede the playing field to competitors. That’s where the FDAnews Guide to International Pharma Regulation: 2013 Edition comes in.