FDA Pharmaceutical and Medical Device Books
Published: July 2012 | Pages: 75 | Price: $377 | ISBN: 978-1-60428-065-4
When is reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? When there is a conflict, which rule applies? Discover the answers — and more — in a new management report from FDAnews.
Published: June 2012 | Pages: 74 | Price: $377 | ISBN: 978-1-60428-061-6
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.
Published: June 2012 | Pages: 372 | Price: $377 | ISBN: 978-1-60428-055-5
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.
Published: June 2012 | Pages: 65 | Price: $377 | ISBN: 978-1-60428-057-9
Congress has started pushing both the FDA and NIH to begin penalizing drug sponsors who do not report on ClinicalTrials.gov. New legislation is also pending in the House of Representatives to increase reporting requirements and also step up penalties.
Published: June 2012 | Pages: 283 | Price: $377 | ISBN: 978-1-60428-059-3
Something’s gone wrong in one of your clinical trials. But ... is it an adverse event? What should you do next? Get the facts.
Published: June 2012 | Pages: 33 | Price: $457 | ISBN: 978-1-60428-035-7
Wondering what would improve your device company’s CAPA performance? We have answers from an exclusive, new FDAnews survey of devicemakers.
Published: May 2012 | Pages: 57 | Price: $377 | ISBN: 978-1-60428-033-3
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.
Published: April 2012 | Pages: 193 | Price: $3,500
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.
Generic and Innovative Drugs Market in Central Europe 2012: Comparative Analysis, Reimbursement Policies and Development Forecasts for 2012-2014
Published: April 2012 | Pages: 303 | Price: $3,500
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.
Published: April 2012 | Pages: 155 | Price: $750
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.
Published: April 2012 | Pages: 231 | Price: $1,495
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.
Published: April 2012 | Pages: 644 | Price: $377 | ISBN: 978-1-60428-031-9
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.
Published: April 2012 | Pages: 124 | Price: $377 | ISBN: 978-1-60428-029-6
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.
Published: April 2012 | Price: $377
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!