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.

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.

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.

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.

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.

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.

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.

This management report from FDAnews, Secrets of Successful Advisory Committee Meetings, brings you the tips and tactics you need to get positive advisory committee recommendations. As the FDA begins to weed out advisory members with ties to drug and device companies, you can still rely on the step-by-step strategies in Secrets of Successful Advisory Committee Meetings to achieve success with the new, more critical round of FDA panelists.

From FDAnews, Generic Challenges to Patent Rights: The Legal Battle maps out trial, pretrial and business strategies for “generic-proofing” patents. From active-ingredient formulation to polymorph, method of treatment and process patents, you’ll learn specific approaches brands can use to deflect intellectual property challenges from generic companies.

Discover step-by-step how you can profit from shorter cycle times, greater product availability, higher yields and more — when you put PAT tools to work at key phases of your manufacturing process. You'll even jump the learning curve with eight dos and don'ts of a successful PAT program.

Glean real-world insight with examples of working change control systems, specifically targeted to the unique needs of drug and biologic manufacturers, with this new management report. Don't delay, order this distinctive management report filled with common sense procedures on change control that you can use today.

This indispensable management report maps out a comprehensive strategy for recall planning. From creating a recall committee to handling communication and policy changes during a recall, you'll be at work with today's best practices for containing damage and keeping your edge.

This management report from FDAnews, shows you how to develop a plan to protect yourself from liability and educate your investigators and staff about the importance of upholding confidentiality agreements. Confidentiality in Clinical Trials: Understand Your Liability is a first-line resource to help you learn what the issues are and what you need to do to keep your data secure and your organization safe from unwanted intrusion.

The most complex corrective and preventive action (CAPA) issues are often found outside the routine channels you may already be using to assess and track CAPAs. Make sure you take all the issues into account based on industry guidances — and uncover tough-to-spot problems, before they trigger an FDA warning letter.

This management report presents a "master plan" of clinical trial planning to help you get your drugs to market faster, ensure adherence to federal regulations and good clinical practices and keep budgets under control.