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Mpower

11/09/10 12:02 PM

#108525 RE: DewDiligence #108522

In a emergency situation (like the Heparin crisis), the FDA P&P manual allows the agency to accept gratuitous services. MNTA did not receive consideration, per se, for the services they provided, but it did provide the company an opportunity to showcase their sophisticated technology and publish a major article.
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zipjet

11/09/10 1:15 PM

#108544 RE: DewDiligence #108522

>>That’s how these kinds of consulting gigs will probably be handled by the FDA in the future.

By the time the RFP was drafted, published in the Federal Register, Proposals are drafted, the requisite certifications obtained, a winner selected, and appeals adjudicated ...

Well you get the idea - perhaps the death total would be 1,000 rather than 100.

ij