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With the progression of technology, it has become evident that there is a place for electronic documentation in clinical research. One area of particular benefit includes the informed consent process. Electronic informed consent (eIC) has the potential to offer great advantages over the traditional paper consent process. If used correctly, eIC can serve as an […]

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While not directly called out as required in the Food and Drug Administration’s (FDA) Quality System Regulation (21 CFR 820), a good Validation Master Plan (VMP) is critical to executing a solid process validation program. A Validation Master Plan provides medical device manufacturers with a roadmap, by outlining the process validation requirements and providing justification […]

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Passed in July 2012, the Food and Drug Administration Safety and Innovation Act has notably changed the Food and Drug Administration’s authority regarding the collection of fees, the manner in which reviews of drug applications are conducted, access of patients to medications, and the participation of stakeholders in the process. The legislation is expected to […]

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Personalized medicine has attracted much interest within the healthcare community during recent years. More physicians are striving to customize their medical treatments to their patients’ unique genetic makeup and circumstances. However, personalized medicine poses a number of regulatory challenges. As such, pharmaceutical executives should understand these challenges and how they affect the industry. What Is […]

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Adverse drug events are among the leading causes of death from approved pharmaceuticals, and illnesses and deaths from these events cost the healthcare system billions of dollars each year. As such, the Food and Drug Administration has regulations regarding the monitoring and reporting of them. Keeping track of these events is important because the full […]

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