Tag Archives: FDAAA 2007

New Informed Consent Requirements Improve Transparency in Clinical Trials

Posted on 17 January 2011 by Ask-Cato.com Contributor

Trust, honesty, humility, transparency and accountability are the building blocks of a positive reputation. Trust is the foundation of any relationship. – Mike Paul Transparency of clinical research to participants and patients is what the FDA is going for with … Continue reading →

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FDA Implements FDAAA 2007 Pediatric Requirement for Device Applications

Posted on 9 April 2010 by Leo DiNapoli

If our American way of life fails the child, it fails us all. – Pearl S. Buck The FDA recently announced that is implementing a requirement from the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007) regarding medical … Continue reading →

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FDA Proposes New Direct-to-Consumer (DTC) Advertising Rules

Posted on 8 April 2010 by Leo DiNapoli

Good advertising does not just circulate information.  It penetrates the public mind with desires and belief. – Leo Burnett The FDA recently published a proposed rule for how risk information should be presented in Direct-to-Consumer (DTC) advertising.  Per FDAAA 2007, … Continue reading →

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