14 Comments

These people all must be dragged out of the black holes they came from and are trying to scurry back to. They need to have their eyes taped open, and then we need to roll the film of the horrors that they wrought upon us. Anything less will allow them to do this over and over and over again.

https://bherr.substack.com/p/the-fallout-is-real?s=w

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Companies pay the FDA at the time they submit a marketing application. This is true for all products regulated by the FDA's centers CBER and CDER. This has been in place since about 1996 and was put in place to increase the fda's resources and expedite the approval of new therapies. In other countries, companies pay fees to the regulatory authorities to review each clinical trial that they run. In the United States the cost is backended to the time they file the marketing application. There's definitely an argument to be made about whether this is appropriate or not. But on the face of it, there's nothing illegal or unethical about this letter in light of the current regulations.

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What a charming and lovey thing to say!!

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Paul: Do you have a link, so we can copy and post on Twitter? Have you been checking out your Twitter or are you under surveillance and being cautious?

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We WILL find out.

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Nothing to see here; current law legalizes bribery:

https://www.accessdata.fda.gov/scripts/cderworld/index.cfm?

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