FDA Pharmaceutical and Medical Device Books
Published: January 2011 | Pages: 137 | Price: $1,500
Contract Research Organizations in Asia 2011 is the research report and directory that will help you find partners in 11 countries to assist you in carrying out safe, accurate and compliant clinical trials. In addition, this report provides an overview of the growth of trials in this part of the world along with Asian healthcare and industry statistics. 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.
Published: January 2012 | Pages: 108 | Price: $377 | ISBN: 978-1-60004-016-6
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?
Published: September 2009 | Pages: 125 | Price: $377 | ISBN: 978-1-60004-085-6
This all-new report from FDAnews walks you through the steps that result in first-class supplier-quality agreements — documents that protect you and your customers from problems.
Published: February 2012 | Pages: 223 | Price: $377 | ISBN: 978-1-60428-020-3
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.
Published: February 2008 | Pages: 102 | Price: $337 | ISBN: 978-1-60004-180-8
Specifically geared to devicemakers, discover how to comply with off-label promotion requirements in the management report brought to you by FDAnews — Device Off-Label Promotion: Case Studies to Prepare for Increased Enforcement. This comprehensive report delivers timely how-to tips, off-label case studies, best practices and more that lets you access 10 targeted compliance strategies for off-label promotions, Avoid foot-in-mouth marketing comments, and know the three types of off-label communications that aren’t violative and what actions your staff must avoid in these situations.
Published: February 2008 | Pages: 287 | Price: $337 | ISBN: 978-1-60004-182-2
Dietary Supplement cGMPs: Final Rule, the management report from FDAnews quickly zeros in on what the most critical areas of these rules mean to your day-to-day operations — and then delivers expert strategies to help you comply with the latest GMP requirements, specifically tailored to dietary supplement manufacturers, save time with a clear, concise “digest” of the FDA’s 700-page ruling, and know when to use exemptions to the rule and how you can request them.
Published: March 2013 | Pages: 295 | Price: $397 | ISBN: 978-1-60428-092-0
Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus. In addition to warning letters, the agency is filing lawsuits and even seizing product. What’s a supplement manufacturer to do? Get up to speed — fast. Take an FDA crash course. How do inspections work? What does the agency expect in document compliance? Which GMP mistakes are most likely to be targeted? Luckily, help is now at hand.
Published: September 2012 | Pages: 102 | Price: $377 | ISBN: 978-1-60428-067-8
Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.
Published: October 2011 | Pages: 26 | Price: $377 | ISBN: 978-1-60004-257-7
This report is the clearest and most practical training available today for avoiding problems with off-label promotion.
Published: September 2010 | Pages: 44 | Price: $377 | ISBN: 978-1-60004-200-3
If you're going to conduct clinical trials or sell drugs in the EU, the way you handle safety reporting will be essential to your success. But navigating EU pharmacovigilance requirements is a complex task that starts in the early stages of drug development and extends right through the drug's life, and it varies subtly from one member state to the next. The only sane way to approach these requirements is to incorporate them into your company's risk-management processes and procedures.
Published: December 2007 | Pages: 950 | Price: $337 | ISBN: 978-1-60004-133-4
No more sifting through mountains of data! Gain easy, CD-access to a comprehensive collection of documents that helps you establish and maintain an eCTD protocol, with the eCTD Digital Handbook from FDAnews.
Published: July 2010 | Pages: 37 | Price: $377 | ISBN: 978-1-60004-118-1
Will the electronic Common Technical Document (eCTD) submission you design today see your drug smoothly through its entire life cycle? Chances are it won’t — unless you make the right decisions now about everything from naming rules to authorship controls. Here’s where to start:
Published: September 2007 | Pages: 114 | Price: $337 | ISBN: 978-1-60428-002-9
Effective Techniques for Monitoring Medical Devices in Clinical Trials, the management report brought to you by RxTrials Institute. Discover the details that will help you quickly distinguish between unanticipated adverse device effects (UADE), adverse events and procedural complications from operator error and reporting each event with confidence, understand the relationship between good clinical practice (GCP) and the monitoring of your medical device trials, and accurately apply risk management principles to GCPs.
Published: November 2011 | Pages: 132 | Price: $377 | ISBN: 978-1-60004-265-2
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.