Tag Archive: FDAAA 2007

Oct 10 2012

Clinical Trial Reporting

On 26 September 2012, a notice was published in the Federal Register that the Department of Health and Human Services was transferring responsibility to the FDA for ensuring that clinical trial data is appropriately submitted to Clinical Trial Registry and Results Data Bank (which is also known as ClinicalTrials.gov) and that the data is complete …

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Jul 09 2012

Unique Device Identifiers: It’s the Law, Almost

When the FDA Amendments Act was signed into law in 2007, one of its many tasks was to create a Unique Device Identifier (UDI) system.  On 03 July 2012, the FDA released the proposed rule for UDIs. The UDI is a code, similar in theory to a barcode, that will be printed on each device …

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Jan 17 2011

New Informed Consent Requirements Improve Transparency in Clinical Trials

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 their amended informed consent regulations. The new regulations stem from the Food and Drug Administration …

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Apr 09 2010

FDA Implements FDAAA 2007 Pediatric Requirement for Device Applications

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 devices and pediatric populations.  Device manufacturers must now: “…provide readily available information in certain premarket …

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Apr 08 2010

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

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, the FDA was mandated to ensure that the description of side effects and contraindications (the …

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