Compliance

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Compliance

What is the final rule's effective date and compliance date?
When must I submit the required clinical trial registration information?
Does the definition of Applicable Clinical Trial under FDAAA 801 only include studies conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)?
To comply with FDAAA 801, must I submit information to ClinicalTrials.gov, or can I use another registry or results database?
Who should submit an Expanded Access record?
Does FDAAA 801 only apply to Industry-sponsored studies?
To which trials do the potential legal consequences described in 42 CFR 11.66 apply?
How are examinations by telephone call or other electronic means considered in determining when an applicable clinical trial reaches its "primary completion date" or "study completion date" under the regulation?

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