Tag Archives: FDA regulates computerized systems used in clinical trials

YOU DID NOTHING: TRUTH BOMB ON FDA

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MONKEYPOX – WE HAVE TWO DAYS TO PROVE TO EVERYBODY THAT THIS IS AN AGENDA AGAIN! – DR DAVE MARTIN

Fauci’s NIAID Received $10M MONKEYPOX Research Grant Last Year: Report https://www.youtube.com/watch?v=HEWSPTnNeb4

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This is a serial killer

This is a serial killer

She KNOWS what she’s doing, that’s the scary part of it

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The FDA and CDC Are Preparing a “Framework” to Exempt Future COVID-19 Shots from Clinical Trials

The FDA and CDC Are Preparing a “Framework” to Exempt Future COVID-19 Shots from Clinical Trials. ICAN is Fighting Back.

ICAN attorneys and research staff watch every meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC’s Advisory Committee on Immunization Practices (ACIP). What is seen over the course of many meetings are the patterns and methods by which these agencies rig the approval process to achieve pre-determined outcomes.  Now VRBPAC and ACIP are gearing up to pre-approve all future COVID-19 shots, regardless of formulation, with no additional clinical trials!
After VRBPAC’s April 6, 2022 meeting, ICAN, through its attorneys, wrote a letter to FDA Commissioner Robert Califf, the members of VRBPAC, and the Senators and Representatives responsible for the FDA’s budget, explaining our concerns in detail.
To summarize, VRBPAC appears to be following the same plan it follows for the flu vaccine every year and we know how well that works. Each year, they engage in “the flu strain selection process” and agree on the strains that will be included in the flu vaccine that year. Vaccine manufacturers love this because they can create a single flu vaccine and sell it worldwide.  Most importantly, however, they can then skip the regulatory review process because these new formulations are automatically deemed safe and effective since they are “biologically similar” to previous versions of the flu vaccine.
The problem from a public health perspective is that this process does not work.  As ICAN has noted previously, at best, FDA’s own data show flu vaccine effectiveness in the previous season was between 8% and 14%.  Evidence from an influenza outbreak at a large university campus showed flu vaccine effectiveness was zero.
What does all of this have to do with COVID-19 shots?  The White House, FDA, and CDC have come up with a disturbing plan: they are proposing to take the flu strain selection process (that does not work) and apply it to future COVID-19 shots!
What this means is that each year, FDA/VRBPAC and CDC/ACIP (under the direction of the WHO) will engage in an elaborate performance of “COVID-19 variant selection.” They will potentially choose between 1 and 4 strains to put into the COVID-19 shots (for example, combining spike proteins from Wuhan, Beta, Delta, and Omicron variants in a single shot).  The worst part?  They will argue that this new formulation is biologically similar to previous COVID-19 shots, and therefore they will not require pharmaceutical companies to conduct any new clinical trials.
ICAN is already fighting back, and you can also take action. You can join us in pushing back before VRBPAC and ACIP meet again in June regarding this proposal by contacting your elected officials today to tell them to reject this dangerous proposal and hold the FDA and CDC accountable if they do succeed. ICAN also intends to legally challenge this proposal if it is adopted but let’s hope that won’t be necessary.

Source: icandecide.org

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#SCIENTIFICFRAUD: PFIZER AND CDC COMMITTED FRAUD

PFIZER AND CDC COMMITTED FRAUD BY WITHHOLDING CRITICAL DATA RESULTING IN HARM AND DEATH TO MILLIONS!

There are people out in the world that legitimately believe that they need me to get a vaccine in order for their 4 vaccine shots to work.

I randomly think about that sometimes and laugh out loud – Candace Owens.

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BREAKING NEWS: Pfizer falsified vaccine trial data.

BREAKING NEWS: Pfizer falsified vaccine trial data.

“But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.”

Source: https://www.bmj.com/content/375/bmj.n2635

Archive link: https://archive.md/hKt13

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Real world evidence emerges daily of IVM’s ability to protect everyone

—the unvaccinated & the vaccinated—against C19.

We know many ignore the science, foolishly believing that the science has a political agenda.

The science has but one message for all:

“You don’t have to die.”

https://twitter.com/jjchamie/status/1438702011357278211?s=21

Source: World Doctors Alliance, [Sep 19, 2021 ]

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FDA Safety Surveillance of COVID-19 Vaccines

Go to page 16 — FDA Safety Surveillance of COVID-19 Vaccines : DRAFTWorking list of possible adverse event outcomes

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-10/COVID-Anderson-508.pdf

FDA Vaccines Adverse Event:

COVID-Anderson-508

If it worked and was safe, you wouldn’t need to run HUGE ad campaigns, mandate it, or offer incentives.

If it worked and was safe, you wouldn’t need to block, censor, and threaten those who question it.

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HEARING WITHOUT LISTENING: FDA COMMITTEE APPROVING AT “WARP SPEED.” CHILLING!

Dr. Arnold Monto, the acting chairman of the vaccines advisory committee, curbed and corralled the discussion to authorize emergency use of the Pfizer vaccine — cutting off questions, limiting debate, and forcing committee members to vote without giving them a chance for any refinement to the authorization. This video is “unlisted” on YouTube… meaning it won’t come up by searching. Here’s the link: https://www.youtube.com/watch?v=SeiBhOai_dI&feature=emb_logo
Thank you Children’s Health Defense for finding it! https://childrenshealthdefense.org/defender/how-fda-approved-pfizer-covid-vaccine-warp-speed/

PLEASE SHARE!!!

Source: MarcusTwain22

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FDA Declares Homeopathic Medicine Illegal

Repost from Health Impact News

Help Us Save Homeopathy!

by Alliance for Natural Health

Help us support our allies in an effort to stop the FDA’s attack on this safe, natural form of medicine. Action Alert!

Our friends at Americans for Homeopathy Choice have submitted a Citizens Petition to the FDA requesting that the agency reverse its recent actions with regard to homeopathic medicine.

Upending decades of safe regulation, in 2018 the FDA released a draft guidance that essentially stated that all homeopathic drugs are illegal.

We cannot let this attack against this safe and effective form of medicine go unchecked.

Recall that the FDA’s guidance document, which lays out the agency’s current position on the regulation of homeopathic drugs, says:

  1. Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug;
  2. FDA has not determined that any homeopathic drugs are GRAS/E;
  3. A new drug cannot be marketed unless it goes through the FDA’s approval process;
  4. No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process.

The guidance also explains that, while all homeopathic drugs are illegal, the FDA will apply a risk-based enforcement approach.

The agency has already begun to apply this doctrine; earlier this year the agency attacked manufacturers of injectable homeopathic medicines.

In our coverage of this recent attack, we pointed out that there is in fact no safety issue with homeopathic medicines, which have a sterling record of safety.

review of the evidence of adverse events related to homeopathy, which included data from 12 European countries, the US, Mexico, India, Israel and Brazil published between 1978 and 2010, found a total of just 1,159 adverse events.

This equates to an average of just over 50 cases per annum across all 17 countries from which studies were conducted. By comparison, foodborne illness contributes to on average of 128,000 hospitalizations and 3,000 deaths annually in the US alone.

Worldwide, an estimated 200 million people use homeopathy regularly, including 6 million in the United States. These data show that adverse events from homeopathic medicines occur at a very, very low rate.

So why go after homeopathic medicines?

The FDA gets a large part of its funding from drug company user fees, and for this reason sees Big Pharma as its client. Homeopathic medicines, like supplements and other natural products, compete with pharmaceutical drugs, so the FDA uses its enormous power to tilt the scales in favor of the drug companies.

And because natural products and homeopathic medicines generally cannot be patent-protected like drugs can, they can’t afford FDA-approval and so cannot make disease claims. It is one of many ways cronyism is undermining healthcare in this country.

Sign our petition below to reform American healthcare. In addition, go to Americans for Homeopathy Choice’s website to submit a comment in support of their Citizens Petition.

Action Alert! Sign our petition to reform our healthcare system that bars and undermines natural options like homeopathic medicine. Please sign our petition immediately.

Source:

Homeopathic

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