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FDA places informed consent on a slippery slope

2 months ago -

In late December 2023, a rule was issued by the FDA allowing certain clinical trials to operate without obtaining informed consent from participants. The rule officially went into effect on January 22, 2024. According to Dr. Robert M. Califf, serving commissioner of Food and Drugs for the FDA, the rule was passed to encourage the discovery of more treatment and diagnostic options in the medical field by reducing administrative burdens. “We anticipate this new ...

FDA approves ANTHRAX vaccine despite its TOXIC INGREDIENTS

August 01, 2023 -

As reported by Fierce Pharma, Emergent BioSolutions has secured a full approval from the FDA for use of anthrax vaccine Cyfendus after supplying the shot for years. Prior to this, Emergent has provided the Department of Health and Human Services with its AV7909 anthrax vaccine for emergency preparedness since 2019.

The FDA's full approval encompasses the anthrax vaccine's use for adults 18 to 65 in conjunction with antibacterial drugs after suspected ...

FDA admits in court case that vaccines still contain mercury

in 2473 years - printable article

FDA admits in court case that vaccines still contain mercury

FDA admits on its website that thimerosal is still in vaccines

Don't believe the lie: Thimerosal is eventually converted by the body into highly-toxic inorganic mercury


FDA rules common ingredient in decongestants DOES NOT WORK

September 19, 2023 -

Many decongestants contain phenylephrine, the most common active compound in many over-the-counter (OTC) medications, such as Benadryl Allergy Plus Congestion.

After a two-day review, the FDA panel announced that the oral decongestant "is not effective" at standard or even higher doses compared to a placebo.

The panel's ruling is not binding, but it strongly suggests that the agency could soon pull its approval of the decongestant.

While phenylephrine is ...

FDA finally admits that cocoa flavonols boost cardiovascular health

May 29, 2023 -

The FDA recently approved a new health claim for high-flavonol cocoa powder, which can help reduce the risk of cardiovascular disease – this according to the latest science.

Any food product that contains at least 200 milligrams (mg) of cocoa flavonols per serving and at least four percent concentration with naturally conserved cocoa flavonols can now bear the claim that it helps to support heart health.

The approval came five years after a filing was made ...

FDA just lost a historic ivermectin lawsuit — so when will FDA officials be arrested and charged with manslaughter for denying lifesaving treatments to Americans?

19 days ago -

Texas court cracks down on FDA and HHS officials

In a historic case, the U.S. District Court for the Southern District of Texas, Galveston Division ruled against the FDA and struck down their war against ivermectin. As part of the settlement, the FDA agrees to take down website and social media posts that warn people not to use ivermectin to treat COVID-19. The defendants in the suit include U.S. Department of Health and Human Services (HHS), HHS Secretary ...

FDA panel unanimously supports new RSV antibody drug for infants

June 14, 2023 -

All 21 members of the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) unanimously voted in favor of the monoclonal antibody nirsevimab on June 8. The committee agreed that the benefits of nirsevimab exceed the dangers in preventing RSV infections for newborns and infants in their initial RSV season. With the AMDAC's decision, nirsevimab is closer to receiving final regulatory approval.

In a separate 19-2 vote, the AMDAC supported the monoclonal antibody's ...

FDA recalls more EYE DROPS due to risk of EYE INFECTION

November 21, 2023 -

CBS News reported that the recall notice issued Nov. 15 arose from potential safety concerns after investigators found "unsanitary conditions" in the facilities where the eye drops were made. This new order came weeks after the regulator also warned consumers against using an earlier batch of products.

The most recent round of recalls involved 28 eye drop products, all coming from lots with expiration dates ranging from November 2023 to September 2025. The products ...

FDA approved 24 drugs in 2022 based on a SINGLE study

August 17, 2023 -

Congress helped expedite industry corruption in 2016

When the 21st Century Cures Act was signed into law in December 2016, the federal government made it easier to accelerate medical product development. The intent of the new law was to “bring new innovations and advances” to patients with both speed and efficiency. However, the law quickly became a portal of corruption, allowing the industry to bypass the once rigorous, evidence-based standards for new drug approvals.

By ...

FDA now admits doctors can prescribe IVERMECTIN to treat COVID-19

August 16, 2023 -

A statement from Ashley Cheung Honold, an attorney for the Department of Justice (DOJ), attested to this admission. According to her statement, the FDA "explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID-19."

Honold's statement came during the course of oral arguments before the Fifth Circuit Court of Appeals in New Orleans. The court had been hearing a lawsuit filed by three physicians – Drs. Paul Marik, Mary Talley ...

FDA greenlights first clinical trials of Elon Musk’s human brain implants

May 30, 2023 -

"This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people," the company said in a statement. "Recruitment is not yet open for our clinical trial. We'll announce more information on this soon."

Project officials said they are "currently focused on giving people with quadriplegia the ability to control their computers and mobile ...

FDA sued for concealing documents related to suppression of ivermectin and HCQ

December 15, 2023 -

The suit was filed by America First Legal (AFL), a nonprofit organization whose stated aim is to “promote the rule of law in the United States, prevent executive overreach, and ensure due process and equal protection for all Americans.”

The group filed a Freedom of Information Act (FOIA) request last August with both the FDA and HHS seeking information about hydroxychloroquine from 2020. They filed a similar request a month later with the two agencies seeking ...

FDA WARNING: Two popular antiseizure drugs have a potentially DEADLY side effect

December 14, 2023 -

This reaction, known as "drug reaction with eosinophilia and systemic symptoms" (DRESS), may start as a rash, but can quickly lead to internal organ injury or death. The reaction can include other symptoms, such as fever, swollen lymph nodes or injury to the heart, kidneys, liver, lungs or pancreas.

Warnings about DRESS must now be added to the "prescribing information" on levetiracetam and clobazam, along with "patient medication guides."

Levetiracetam was approved ...

FDA warns 3 baby formula makers over violations of food safety standards

September 07, 2023 -

On Aug. 30, the FDA issued its warnings to ByHeart Inc., Mead Johnson Nutrition under the Reckitt Benckiser Group and Perrigo Wisconsin LLC. The letters reflected findings from inspections over the last several months, which found that the three failed to ensure their infant formulas were not contaminated throughout the manufacturing process.

The letters read that these manufacturers "did not establish a system of process controls covering all stages of processing ...

FDA says RECALLED sleep apnea machines are linked to 561 deaths since 2021

February 07, 2024 -

The regulator made this revelation in a Jan. 31 notice, saying that there have been more than 116,000 medical device reports – including 561 deaths – over the now-recalled devices. The reports stemmed from foam breaking down in certain Philips Respironics ventilators, bi-level positive airway pressure (BiPAP) sleep therapy devices, and continuous positive airway pressure (CPAP) machines that were included in a major recall announced in June 2021. (Related: A majority of Americans ...

FDA commissioner pushing off-label pharmaceutical use in illegal Big Pharma marketing scheme

January 18, 2024 -

It was after his first appointment to the FDA role under Barack Obama that Califf proposed that drug companies be allowed to advertise their products for off-label uses. Though illegal, Califf's proposal would have opened up the floodgates for new Big Pharma profit streams, which for many drugs dries up once the market has become saturated for their approved uses.

At the time, Sen. Ed Markey (D-Mass.) wrote a scathing letter to Califf, explaining to him that ...

FDA forced to release documents admitting they knew COVID vaccines caused heart inflammation

December 15, 2023 -

FDA knew there were serious health issues with COVID vaccines but approved them anyway without transparency

Since these EUA “vaccines” are a medical intervention, the transparency of the supporting data is necessary to the informed consent principle, to assist medical providers and individuals in making sound choices for their bodies and their future. If there was a shred of scientific integrity in our government institutions, then the clinical data should have been ...

FDA pulled an UNFORGIVABLE ivermectin swindle during covid and must be held accountable

August 18, 2023 -

The FDA itself spearheaded a disinformation campaign aimed at tricking the country into believing that ivermectin is just a "horse de-wormer," conveniently failing to mention that it is widely used throughout the world in humans to treat similar maladies.

It just so happens that ivermectin is a powerful remedy for covid – and it is cheap, too – so the establishment had to try to discredit it in order to funnel a maximum number of people into "official" protocols ...

FDA recalls green organic kiwifruit from 14 states due to potential LISTERIA contamination

August 15, 2023 -

After testing on the affected fruit revealed the presence of Listeria monocytogenes, a potentially deadly infection, the United States Food and Drug Administration (FDA) issued a recall, tracing the contamination back to two particular kiwi growers in New Zealand.

The recalled kiwis were repackaged locally for the U.S. market in one-pound clear plastic clamshells bearing the Zespri brand name and UPC code 8 18849 02009 3. The affected fruit also has a sticker ...

FDA warns against using COVID-19 at-home test due to bacterial contamination

May 25, 2023 -

The product recall is due to significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution provided in the test kit. The FDA warned that direct contact with the contaminated liquid solution may pose safety concerns and that the bacterial contamination could impact the accuracy of the test.SD Biosensor Pilot COVID-19 At-Home Tests recalled

SD Biosensor, Inc. has initiated a recall for all impacted SD Biosensor Pilot COVID-19 At-Home ...

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