New FDA Inspections’ Database — How Useful for FDA-Regulated Industry?

The new Inspections Database (http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm) is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement actions and results across the country and rest of world. It is certain that the information will be of value to those parties that are interested in which...
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UPDATE: Free FDA GMP / QSR Ebooks for IPhone, IPad

This is an UPDATE to a post from May 2010. Please click this link for the original post. On Monday, June 21, Apple released the IPhone OS4.    This update to the Apple IPhone operating system added great new features such as multitasking, folders and more.    Also, along with this release, Apple released a great new application for the IPhone:   iBooks! From the Apple website: ...
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Webinar, June 23: Inspection Readiness for a More Aggressive FDA

Join the Center for Business Intelligence for a one-hour, information-packed webinar on managing FDA  inspections from a more aggressive FDA.   Now that pharmaceutical, medical device, dietary supplement, and biologics’ companies know that the FDA is back on the hunt for non-compliant companies, what can your company do about it? The short answer is be prepared! This webinar will...
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Will Robinson – Soldier, Family Man, Professional, Friend – RIP

Memorial Day Week is a fitting time to learn of the passing of a professional colleague and someone that I am proud to have considered a friend.  Willie Horace (Will) Robinson died suddenly on May 24, 2010.   As with all of those we love and care about, the loss of a colleague, friend or family member is difficult.  Thinking about Will makes me sad; as the world has lost a wonderful man, and...
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Ensuring Supply Continuity for Medically Necessary Drug Products

THE FOLLOWING POST IS FROM FDANEWS.  For additional information, please see: Ensuring Supply Continuity for Medically Necessary Drug Products The ink is barely dry on the draft MNP guidance, and the pressure is already on many drug and biologics manufacturers to develop emergency plans to meet FDA requirements. Here’s how to get up to speed — fast. Ensuring Supply Continuity for...
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