Good Day! I’m catching up on all the Federal Register updates, and saw this one regarding the validation of diagnostics during an emergency.
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
By now y’all know that emergencies = fuckery, and are a means by which rights are usurped and things like standards and definitions become flexible.
If you’re curious about how testing was used to pull off the covid not a pandemic, I wrote about it here:
Now, let’s have a look at the Validation of Certain In Vitro Diagnostic Devices During an Emergency.
Just so we are clear…
in vitro = in a lab
My goodness it doesn’t take long to get to the bullshit.
By page 7 they come right out with it.
Apparently an outbreak of disease could be marked by a lack of available specimens.
This is hilarious.
Let’s just work through it for a moment. How do we know there’s an outbreak? Sick people, right? And sick people have symptoms (because that’s how they know they are sick).
I mean we can’t have an asymptomatic (brand new disease) outbreak…
Or can we??? Maybe we’re having one right now…🧐
Just kidding.
One can assume that symptoms would produce a specimen. Like snot or vomit or diarrhea or covid toe.
Welp, apparently one would be wrong.
FDA just wants to cover all their bases I guess, or maybe I just don’t understand outbreaks…but in the case of no specimens (which according to this document might happen in the beginning of an outbreak), FDA suggests using “contrived (spiked) specimens” or “synthetic material”.
A contrived specimen refers to a sample that has been artificially created or manipulated to simulate a real biological specimen or to mimic a specific condition for testing purposes. The term is most commonly used in the context of laboratory tests, drug testing, or clinical trials, where a contrived specimen may be intentionally altered to meet certain parameters or conditions. This manipulation can be done for various reasons, such as controlling variables, testing methods, or preventing interference in the analysis. 👉 Or when you need to fake a pandemic.
What I really love is how they immediately follow up this recommendation with the caveat that contrived samples aren’t valid.
You guys. THIS IS HOW THE FUCKERY GETS DONE, and they are telling you outright. Hey, this is how we did it with Covid and it worked so well that we are codifying it with this bullshit draft guidance👇
Moving on to page 21, where we have some more sleight of hand.
Predetermined Change Control Plans
Let me rephrase this.
👉 If you are applying for an EUA, you can make up different ways that you could use your bullshit test in the future and include those in the application. Then, when your original bullshit test is approved, your imagined future bullshit will also be authorized.
This reminds me of surrogate endpoints, where an endpoint that’s not the endpoint is used. And 505(b)(2) New Drug Application (NDA) and Abbreviated New Drug Application (ANDA), where drugs are approved based on similarity to already approved drugs.
I guess those methods have already worked pretty well for getting people mass poisoned. Might as well get the ball rolling on codifying the process for “tests”.
I mean, this house of mirrors isn’t going to build itself…
😅
All the AI world's a stage. - Shakespeare GPT
hola, sarah.
great dig and for me a lovely synchronicity with jeff childers' working through the florida grand jury's report at the criminal-like behaviour of the fda/cdc and their masters, pfizer, moderna, et al. the progressives including, very likely, their mockingbird press were just about shitting their pants with joy — no criminal charges!
oops. only because the perpetrators of the crime, can't be charged — as government agents they have immunity! and because what they did is criminal and yet the crime hasn't been legislated that they could use!
the report shredded the fda and fhe cdc as unethical and criminal in their behaviours. likewise the pharmas.
here's the link to the whole report. https://floridaphoenix.com/2025/01/07/statewide-grand-jury-investigating-covid-19-vaccines-finds-no-evidence-of-crimes/
it is long! childers' summary is a great introduction. his point summary is:
· The real criminals were in the U.S. government, and so, unfortunately, are protected from state prosecution.
· Pfizer and Moderna protected themselves by disclosing everything to the FDA, which was and is running interference for them.
· There is no reliable evidence that the vaccines are safe or effective, especially at this point.
· The problem was and is that many corners were cut, facilitated by regulatory agencies, and we now may never know the full scale of the disaster.
· The data that could really answer questions of safety and efficacy have never been, and probably never will be, disclosed to the public.
some of the citations childer's cited could have been referring to exactly this!
"While we did not find criminal activity, we did find a pattern of deceptive and obfuscatory behavior on the part of sponsors and regulators that often straddled the line between ethical and unethical conduct. More importantly, however, not finding any indictable criminal activity does not mean we did not find any problems. On the contrary, there are profound and serious issues involving the process of vaccine development and safety surveillance in the United States. Some of those are acute, COVID-19-era problems that are unlikely to occur outside the context of another once-in-a-hundred-year pandemic. Others, however, are systemic; they will occur over and over until someone fixes them."
and
"To date, Moderna has not completed any of its other postmarketing requirements. All of the studies above except for No. 11, which was terminated, are still underway… The FDA would not speak to us directly, so we are not sure what their excuse would be for not holding Pfizer and Moderna's feet to the fire. Frankly, we are not sure any answer would satisfy us at this point, nor should it satisfy anyone else."
and
"It is frustrating to this Grand Jury, as it should be frustrating to everyone who reads this report, to know that these sponsors have taken in billions of taxpayer dollars for creating and selling their vaccines; they cannot be sued if something goes wrong with them; they have access to critical information about deaths related to a side effect of their products; and the public does not have access to that information. Instead, we are left to speculate, and the research community is left to draw inferences as one-off or two-off histopathological reports detailing the events of this death or that death that trickle into scientific journals slowly, year after year. Somehow, withholding this valuable safety information is not a crime. It certainly should be."
there is a lot more. i share this in part because childers is concerned that the msm will whitewash it — have already begun that. and yet is reflecting everything you are exposing, from the angle of looking at the broken eggman and trying to see if it is fixable. i doubt it is fixable eve if the money was removed from the equation — and if that happened that would be amazing.
yes, fda/cdc gives the carte blanche and the instruction manual to fake the sicence™ and gaslight the public.
with deep appreciation for more of your diligent and great work with tedium.
all the best with what has changed in 2024! and with everything that is to change in 2025! everything changes! with peace, respect, love and exuberant joy.
🙏❤️🧘♂️🙌☯️🙌🧘♂️❤️🙏