The article also states that BP said “The timing of the correspondence coincides with refreshed leadership at the newly formed Office of Therapeutic Products (OTP) within CBER at the FDA and the release of draft industry guidance for demonstrating effectiveness in one adequate, well controlled clinical investigation with confirmatory evidence.” May be this time they are going to finally do the right thing with new leadership at OTP?
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The article also states that BP said “The timing of the...
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