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 FDA adopted ICH Q10 for good reason: The lifecycle approach to drug GMP promises to improve quality across the board. A pity, then, that most drugmakers didn’t use a lifecycle approach when ICH Q10 made its bow ... and didn’t have a clue as to how to begin. Many still don’t. But worry not — help is at hand.

This management report from FDAnews provides drugmakers and suppliers with a thorough overview of the EU’s risk management approach.

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.

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

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.

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 …

China Pharmaceutical Market Report 2011 is the research report that contains key information on important aspects of the Chinese pharmaceutical market. This book provides an overview of current conditions in the Chinese healthcare market. It is an invaluable resource, whether you are planning to expand your reach into China for the first time or simply need a veteran’s perspective on the country’s marketplace to manage your ongoing efforts.

China Pharmaceutical Regulatory Report 2011, the research report that gives you a thorough understanding of the Chinese regulatory structure governing the drug industry. You’ll get a complete discussion of the laws and regulations that govern the testing, product registration, manufacturing, importing, marketing and sales of pharmaceuticals. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided hundreds of companies with regulatory information and business strategies to develop Asian markets.

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.

Something’s gone wrong in one of your clinical trials. But ... is it an adverse event? What should you do next? Get the facts.

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.

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.

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.