By Raymond A. Huml
This short defines aggressive intelligence (CI) as a device for making funding judgements in the pharmaceutical undefined. It presents an summary of methods that the regulatory affairs expert needs to keep in mind whilst comparing info impacting product-based danger reviews. those observe fairly to reviews that concentrate on outputs comparable to regulatory approval, or the economic influence of product labeling at the revenues forecast over a restricted time frame. The short additionally offers an summary of highbrow estate review that could effect a product’s lifespan out there as a result of patent defense itself (or lack of patent safety) or through regulatory exclusivity. Case examples are mentioned to demonstrate the significance of maintaining with the ever-changing rules, and the way to interpret them within the context of CI. moreover, there's a part on digital facts rooms (VDRs) which at the moment functionality because the cornerstone of due diligence investigations. whereas aimed basically at regulatory affairs execs within the usa, this booklet presents an invaluable adjunct for different pharmaceutical executives, particularly these new to product-based investments, and regulatory affairs pros in different areas.
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This is part of OPDP’s remit to ensure that prescription drug information is truthful, balanced, and accurately communicated. Two examples of such violations are the following hypothetical text messages: • “According to research by Dr. Gardner at UC Berkeley, taking Brand X will reduce your blood glucose level by 8%. ” • “Mr. Anderson, thank you for your comments on this finding. , Brand X), and (3) highlights information about specific research. As regulations have become tighter and more complex, tools like Facebook’s Share Widget now have character input constraints and it is not always possible for a PCS provider or a drug manufacturer to reveal all potential information.
Turner JR, 2009, Drug safety, medication safety, patient safety: An overview of recent FDA guidances and initiatives, Regulatory Rapporteur, April issue, 4–8. 5. Turner JR, Satin LZ, Callahan TS, Litwin JS, 2010, The Science of Cardiac Safety: Centralized Approaches for Phase III Studies Enhance the Quality and Integrity of Collected Data. Applied Clinical Trials, November Supplement, 1–5. 6. Satin LZ, Durham TA, Turner JR, 2011, Assessing a Drug’s Proarrhythmic Liability: An Overview of Computer Simulation Modeling, Nonclinical Assays, and the Thorough QT/QTc Study.
Hoboken, NJ: John Wiley & Sons. 4. Turner JR, 2009, Drug safety, medication safety, patient safety: An overview of recent FDA guidances and initiatives, Regulatory Rapporteur, April issue, 4–8. 5. Turner JR, Satin LZ, Callahan TS, Litwin JS, 2010, The Science of Cardiac Safety: Centralized Approaches for Phase III Studies Enhance the Quality and Integrity of Collected Data. Applied Clinical Trials, November Supplement, 1–5. 6. Satin LZ, Durham TA, Turner JR, 2011, Assessing a Drug’s Proarrhythmic Liability: An Overview of Computer Simulation Modeling, Nonclinical Assays, and the Thorough QT/QTc Study.