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To: norsky; little jeremiah; smileyface; blu; Typelouder

Woah...

Ok now, who was asleep at the insert factory?

This should be sent to anyone pushing people to get the shots...


1,154 posted on 05/08/2021 8:47:18 PM PDT by WildHighlander57 ((WildHighlander57 returning after lurking since 2000))
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To: WildHighlander57; norsky; little jeremiah; blu; Typelouder

I have rethought my initial “WOW WOW WOW” response to the blank Package Insert. What goes into a Package Insert arises from a prolonged negotiation with the regulatory agency (FDA in the US) from the licensure trials as well as the peer-reviewed literature. Every graph, every table, every comma, every WORD. Only the verbiage in the PI can be used for sales and promotion. Since these therapies are all available under EUA, this process has not taken place yet.

I have not had first hand experience handling the drug products for a trial, but kinda recall something in the cobwebs from discussions with colleagues that the Package Insert information is blank, as a placeholder for future labelling.


1,218 posted on 05/09/2021 4:11:21 AM PDT by smileyface ("The illuminati's whole philosophy demands the use, abuse, sacrifice and consumption of children.")
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