Just released from FDAnews — Investigations Operations Manual 2012 — the FDA’s own internal guidance on how to inspect a drug or device company.

Many CROs and sponsors are speeding recruitment and cutting the costs of clinical trials by conducting them in Central Europe. But not every Central European country is a good choice for every product. You need to understand the specialties and healthcare strengths of each country, the major CROs in the region, what drugs are already being tested, and which countries generate registration delays, as well as the impact of revised clinical trials regulations in Europe. You can’t afford to commit to a location only to discover that restrictive legal requirements and registration delays eat up your development time and budget. Here are the facts, insights and forecasts it takes to get the decision right.

For the makers of generic and innovative drugs, Central Europe’s six countries represent a valuable market. The market, however, is being redrawn by legislative and regulatory actions that change everything from reimbursement policy (and margins), to drug patent expiry and data exclusivity periods. Add in challenges from counterfeit drugs and new patient and physician mindsets, and “business as usual” can put even established players at risk. Here is how to understand this new market environment — and spot where your own best opportunities exist.

In this clear yet comprehensive new resource developed by Access China Management Consulting Ltd., FDAnews provides an English-language guide that makes it easier to navigate the Chinese medical device registration system.

With a new resource developed by Access China Management Consulting Ltd., FDAnews offers non-Chinese companies the know-how to move into China’s lucrative pharmaceuticals market without giving up their intellectual property rights.

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.

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.

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!

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.

You know there’s money to be made in the global generic drug market. But which countries are up, which are down and which are coming into their own? Which companies are working together, who’s suing whom and how could developments inside top industry players affect expansion for makers of generics and biologics? Here are the answers you need today to identify the best —and safest — business prospects for the years ahead. Order today.

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 FDA’s fast-tracking of two molecularly targeted cancer drugs signals a major shift in medicine — and the cancer therapy marketplace. Today, Pfizer and Roche have an edge with their newly approved drugs. But analysts say the flexibility of smaller companies could ultimately give them the edge in new market niches where therapies no longer focus on where the cancer is located, but the cells’ molecular make up and the patient’s genetic factors. Whether this shift represents a concern or an opportunity depends on how you navigate the next five years. Here’s how to see what’s coming — today.

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.