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A comment on Johnson and Johnson single-shot vaccine appears 66% effective in global trial. Parent comment

Re:Johnson and Johnson single-shot vaccine appears 66% effec... by jpeloquin on Friday January 29, 2021 @12:22PM (#25959783)
> I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous.

Is this referring to all of the submission pathways, or one in particular? That is, I wouldn't expect the 510(k) process to be particularly rigorous, but the PMA process should ratchet up the scrutiny.

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Re:Johnson and Johnson single-shot vaccine appears 66% effec... by abfan1127 on Friday January 29, 2021 @12:58PM (#25960233)
Its been 10 years since that employment so I don't recall the details. We would get annual "FDA training" on how to report, document, etc. my particular employer always stressed on being accurate and doing what was right for the patient. But "over-reporting" was discouraged... I always related it to a police investigation. Don't give them any more information than asked, you never know what rabbit hole they will go down, risking rejection.
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