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.

When it comes to valuing a company’s assets, bricks and mortar are the least of it. For most life sciences companies, the core value of a company’s assets lies in intellectual property — patents, copyrights, trademarks, secret processes.

This new-and-revised collection from FDAnews draws on the experience of thousands of trial sites worldwide. They’re compiled from stories that first appeared in Clinical Trials Advisor newsletter, the industry’s trusted source of management and compliance guidance.

In this new resource from FDAnews, you’ll find what you must know to create a clinical data management plan that combines trouble-shooting best practices with insider intelligence of exactly what you’re likely to encounter during an FDA inspection.

Getting Your Drug Approved is organized with reader convenience in mind. You’ll discover sections organized in logical order, plus guidance for each step of the approval process — formatting, documentation, necessary certifications and reviews, inspections and the internal policies and procedures the FDA uses to evaluate drugs, investigational drugs and generics.

In drug manufacturing, success means staying abreast of regulatory changes from Asia to Argentina ... and beyond. Impossible? Not at all.

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

Before you begin to modify an existing trial, this new report from FDAnews maps out the specific planning and preparation it takes to win FDA approval for adaptive clinical trials. By combining a concise overview with a detailed analysis of FDA’s preferences, this one report advises you on everything thing from the best trial model to use to the best way to avoid technical problems with final data analysis.

The all-new edition of this FDAnews bestseller provides an overview of each of the CDER policies that are important to you, as well as the full-text versions of those 150 policies in a fully searchable CD. In total, it contains more than 1,100 pages and 23 sections, covering topics ranging from document development and management through review and more!

What would FDA inspectors say if they walked into your lab today and looked at your training records? Are your SOPs up-to-date and complete? Would your sample-handling procedures and archives win praise from an auditor? If you have any doubts, now is the time to take action with this 10-step approach to ensuring quality in GLP-compliant labs…

Are you struggling to cope with negotiating dozens of supplier quality agreements? What topics need to be addressed in every quality agreement? What changes at your suppliers’ operations do you need to know about? Does every supplier even need to have a quality agreement?

No question about it: social media presents a host of problems for drug and device companies. Still, for brands that manage their presence successfully, the upside potential is huge. But what’s the secret to keeping control over your brand as people share on social media? What does an FDA-proof social media presence look like? What happens if consumers use YouTube, Twitter or Facebook to report previously unknown adverse events? How do you present balanced promotions and important safety information using social media? Here’s how to develop a social media strategy that keeps you compliant and competitive.

At last, the FDA has published guidance and recommendations that will take the uncertainty out of using electronic source documentation in clinical trial records. Now there are answers that will clear up the questions that for years have plagued sponsors and CROs attempting to shift to an all-electronic environment. This new report is designed especially to help you clarify the FDA’s recommendations — and put them into action. Read on.

Here in one authoritative source is what clinical trial sponsors must know before venturing into China. This management report provides an overview of China’s current regulatory landscape and points out key differences from US and European requirements.

The Guide to FDA Pharma GMP Regulations – 2011 is a compilation of pharmaceutical GMP regulations that puts all the authoritative information you need in one place.