FDA Pharmaceutical and Medical Device Books
Published: July 2008 | Pages: 197 | Price: $337 | ISBN: 978-1-60004-002-3
Tune Up Your CAPA System: A Practical Guide, the management report that will take you through the latest trends in FDA CAPA enforcement, highlight the deficiencies that inspectors are finding and offer you insight into where you should look to determine the effectiveness of your CAPA systems. This management report includes an expert analysis of real-life warning letters and a step-by-step guide to what the FDA looks for when it inspects your CAPA system. Plus, you’ll get a list of best practices to make sure your system can stand up to the agency’s scrutiny.
Published: July 2008 | Pages: 159 | Price: $347 | ISBN: 978-0-98176-350-7
Finally, there is one book that provides all the tools you need to prepare for an FDA advisory committee meeting, from detailed timelines and messaging tips to rules for crafting effective slides and handling the toughest questions.
Published: June 2008 | Pages: 30 | Price: $327 | ISBN: 978-1-60428-013-5
Clinical Trials Indemnification Clauses: Pitfalls and Problems to Avoid is the management report that examines the most problematic areas in negotiating indemnification clauses. This report highlights the key topics you need to address and provides insight into the types of agreements that are generally accepted standards in the industry.
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: January 2008 | Pages: 64 | Price: $337 | ISBN: 978-1-60004-184-6
Reportedly Trained or Truly Trained: Developing GMP Training that Works, this unique report from FDAnews details what your training program must include to be effective including two areas that should become your training focus and will yield a return on investment, four root causes of inadequate training, three domains of educational activity, four ways that adult learners effectively perceive information, and the six levels of learning and how to determine which level is appropriate for specific tasks.
Published: December 2007 | Pages: 300 | Price: $592 | ISBN: 1460-8375
From FDAnews (published by Euromed Communications), this loose-leaf manual shows you how to satisfy all European regulations affecting your medical devices. You’ll find clear, practical and up-to-date guidance for every class of medical device and at every stage in the product life cycle, from selecting your conformity assessment route to registering with a competent authority and complying with global harmonization.
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: December 2007 | Pages: 139 | Price: $337 | ISBN: 978-1-60004-178-5
From FDAnews — Adverse Event Compliance in Device and Diagnostics Clinical Trials. Find clear, concise guidelines on adverse event reporting — specifically for device and diagnostics trials. Make sense of all the whats, whens and hows surrounding adverse event reporting. Once an adverse event happens, it’s too late: you have just 10 working days to submit to the IRB and 10 days after that to get results to the FDA. Stay in control, even when unanticipated events happen.
Published: December 2007 | Pages: 27 | Price: $337 | ISBN: 978-1-60004-166-2
Managing SAS Validation Processes: Mastering the Five Critical Programming Obstacles, the management report from FDAnews, is one of the most widely used software systems in pharma development environments, so your programming expertise will pay off now — and for years to come.
Published: September 2007 | Pages: 67 | Price: $337 | ISBN: 978-1-60004-164-8
Negotiating an FDA Import Hold Crisis: Strategies for Challenging FDA Findings, a management report from FDAnews, maps out every aspect of an import hold, including how to fix problems before they land your shipment in trouble with FDA and customs officials, the best way to train your team to use the right (and avoid the wrong) approaches with FDA personnel and when to activate a rapid-response strategy that gets your imports off hold and into use fast.
Published: September 2007 | Pages: 81 | Price: $337 | ISBN: 978-1-60004-144-0
Treatment INDs: Responding to Risks Created by Expanded Access, the management report from FDAnews gathers detail-driven advice on how to protect yourself from the risks — while maximizing the rewards — created by the FDA’s newly proposed rules on experimental drugs. You’ll also learn how to understand groups and individuals that can gain access to your experimental drug. Don’t wait for a liability lawsuit — or the damaging bad press — that can result from adverse events caused by unapproved drugs. Find out where the FDA is headed now.
Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market
Published: September 2007 | Pages: 96 | Price: $1,500
Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market is the research report that tells you how to obtain orphan drug status for products in Asian countries and the benefits that go along with it. This invaluable guide to Asia reviews orphan drug regulations across the continent and discusses crucial business issues unique to that part of the world. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided more than 200 companies with regulatory information and business strategies to develop Asian markets.
Published: September 2007 | Pages: 27 | Price: $337 | ISBN: 978-1-60430-000-0
Quality of Life Claims, Marketing and the FDA: Creating a Competitive Advantage in a Crowded Market, the management report from Value of Insight (VOI) Consulting, Inc. and FDAnews maps out what’s required to pass muster with CDER and DDMAC — and how to avoid extra trial costs by building in QoL data-gathering right from the start. By combining exclusive surveys with real-world guidance, Quality of Life Claims, Marketing and the FDA helps you zero in on your own best strategy. Plus, you’ll learn how companies have used QoL claims and marketing to turn pipelines from lackluster to blockbuster.
Published: September 2007 | Pages: 143 | Price: $337 | ISBN: 978-1-60428-000-5
Recruitment and Retention in Clinical Trials: What Works, What Doesn’t and Why shows you how to trade outdated strategies for clinical trial retention and recruitment solutions that get your therapies to market faster — and for less. This one source connects you with today’s most innovative, effective tools and tactics. From turning physicians into powerful allies, to simple education strategies that can boost recruitment 50 percent, you’ll discover how to win participation from a wider pool of subjects and keep them on board.