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louieblouie

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louieblouie

Re: exwannabe post# 16657

Sunday, 10/13/2013 8:33:07 AM

Sunday, October 13, 2013 8:33:07 AM

Post# of 428841
While the law may say this....what do the Code of Federal Regulations say relating to that section of law? Is there anything on a time requirement for disclosure of this new issue by the FDA?

For example - if the FDA knew several months ago about this change in science which may significantly alter the study - don't they have a responsibility to notify the company timely as opposed to allow them to continue the study in good faith spending loads of money for an exercise of futility?
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