U.S. Food and Drug Administration – Pandemic Timeline https://pandemictimeline.com Chronological Sequence of Events Tue, 05 Sep 2023 00:35:42 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 https://pandemictimeline.com/wp-content/uploads/2021/06/Covid-150x150.ico U.S. Food and Drug Administration – Pandemic Timeline https://pandemictimeline.com 32 32 FDA grants approval for Plaquenil (hydroxychloro­quine sulfate, aka HCQ) https://pandemictimeline.com/1955/04/fda-grants-approval-for-plaquenil-hydroxychloroquine-sulfate-aka-hcq/ Tue, 19 Apr 1955 00:00:55 +0000 https://pandemictimeline.com/?p=15 Hydroxychloroquine has a long history of use for the prevention of malaria.  It has been considered to be a very safe drug for several decades. The “off label” policy of the FDA allows doctors to prescribe medications for any condition, as they see fit.  An approved drug does not need additional approvals for a doctor…

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Hydroxychloroquine has a long history of use for the prevention of malaria.  It has been considered to be a very safe drug for several decades.

The “off label” policy of the FDA allows doctors to prescribe medications for any condition, as they see fit.  An approved drug does not need additional approvals for a doctor to choose to use it for another purpose that was not part of the initial application for approval.  Additional conditions for which a drug has been found to work may be added to the label information later, but doctors are able to prescribe for those conditions at any time after the drug’s initial approval.  Once approved, the drug is legally available for any use.

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]]> Stromectol (Ivermectin) is approved by the Food & Drug Administration. https://pandemictimeline.com/1996/11/stromectol-ivermectin-is-approved-by-the-food-drug-administration/ Fri, 22 Nov 1996 00:00:33 +0000 https://pandemictimeline.com/?p=1068 Ivermectin is an anti-parasite medication. Ivermectin is used to treat infections in the body that are caused by certain parasites. — The Vigilant Fox 🦊 Sources:

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Ivermectin is an anti-parasite medication. Ivermectin is used to treat infections in the body that are caused by certain parasites.

— The Vigilant Fox 🦊

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]]> AAPS files suit against FDA https://pandemictimeline.com/2020/06/aaps-files-suit-against-fda/ Tue, 02 Jun 2020 00:00:15 +0000 https://pandemictimeline.com/?p=4158 Sources:

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]]> FDA issues Class I recall on Innova SARS-CoV-2 Antigen Rapid Qualitative Test https://pandemictimeline.com/2021/06/fda-issues-class-i-recall-on-innova-sars-cov-2-antigen-rapid-qualitative-test/ Thu, 10 Jun 2021 00:00:17 +0000 https://pandemictimeline.com/?p=816 Innova’s kit includes a nasal swab and a lateral flow test strip, which in less than a half-hour produces colored lines to display a positive reading, similar to a pregnancy test. However, the FDA said that false-negative and false-positive results may lead to delayed diagnoses, inappropriate treatment and the further spread of the virus. Though…

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]]> Innova’s kit includes a nasal swab and a lateral flow test strip, which in less than a half-hour produces colored lines to display a positive reading, similar to a pregnancy test. However, the FDA said that false-negative and false-positive results may lead to delayed diagnoses, inappropriate treatment and the further spread of the virus.

Though Innova previously applied for a regulatory green light, the test has not been authorized or approved by the FDA for use in the U.S.—however, during inspections of the company’s California facilities in March and April, FDA investigators said they found the test was already being sold and distributed.

Innova contracted with the Chinese manufacturer Xiamen Biotime Biotechnology to produce the tests for international distribution.

The company said it plans to seek an emergency use authorization and comply with all FDA requirements.

See FDA lists for other tests that should not be used.  There are hundreds of them on the lists.

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]]> FDA tweets against ivermectin https://pandemictimeline.com/2021/08/fda-tweets-against-ivermectin/ Sat, 21 Aug 2021 00:00:36 +0000 https://pandemictimeline.com/?p=14301 The FDA tweeted, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” Sources: See also, on this site: Stromectol (Ivermectin) is approved by the Food & Drug Administration. Appeals court sides with doctors on ivermectin

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The FDA tweeted, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

Sources:

See also, on this site:

]]> FDA approves Comirnaty COVID-19 Vaccine https://pandemictimeline.com/2021/08/fda-approves-comirnaty-covid-19-vaccine/ Mon, 23 Aug 2021 00:00:00 +0000 https://pandemictimeline.com/?p=4453 There is a rumor going around that the approval is for the name change. After looking at the Approval Letter from the FDA’s Comirnaty and Pfizer-BioNTech COVID-19 Vaccine page, it does appear to be the licensing letter for the inoculation.  This is apparent in the terms used, which are different from those in an Emergency…

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There is a rumor going around that the approval is for the name change. After looking at the Approval Letter from the FDA’s Comirnaty and Pfizer-BioNTech COVID-19 Vaccine page, it does appear to be the licensing letter for the inoculation.  This is apparent in the terms used, which are different from those in an Emergency Use Authorization.  Compare the language used in the approval letter with those issued with the EUAs.  It looks like there are still some final details that are being worked out; otherwise, it appears that the Comirnaty inoculation is now fully approved for sale.  As of yet, the Comirnaty jab is not available in the US.  The Comirnaty/Pfizer-BioNTech Fact Sheet for Healthcare Providers Administering Vaccine clearly states that pre-authorization Pfizer-BioNTech vaccine and the Comirnaty vaccine are equivalent.  However, a recent judicial ruling claims that there is no legal equivalency, and they are not interchangeable.

  • Food & Drug Administration
    October 20, 2021. “Fact Sheet for Healthcare Providers Administering Vaccine [Pfizer-BioNTech].” US Food & Drug Administration. https://www.fda.gov/media/144413/download.
    Food & Drug Administration.
    This document has instructions for healthcare providers who are administering the vaccines.

However, another letter from August 23, 2021, admits that there are differences between the Pfizer-BioNTech vaccine and the Comirnaty vaccine, though they are not spelled out.

The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

The FDA is saying that the products are legally distinct.  They are not the same.  A case can be made that if the recipient did not receive a jab that did came out of a vial with a Comirnaty label, they did not receive the approved vaccine.

The Approval Letter ends thus:

POST APPROVAL FEEDBACK MEETING

New biological products qualify for a post approval feedback meeting. Such meetings are used to discuss the quality of the application and to evaluate the communication process during drug development and marketing application review. The purpose is to learn from successful aspects of the review process and to identify areas that could benefit from improvement. If you would like to have such a meeting with us, please contact the Regulatory Project Manager for this application.

So, if we have concerns, we have been invited to share them.

Meanwhile, the trials have NOT been completed.  Furthermore, the trial has already been unblinded and is thus no longer a randomized control trial.  The Phase III trial is not scheduled for completion until May 2, 2023.  In other words, Comirnaty was approved prior to completion of required trials.

Page 14 of CCCA report: Pfizer did not follow established protocols

I believe that Dr. Jane Ruby in the interview below has properly assessed the situation.  In discussing the proposed Comirnaty package insert, she said:

This document is so paltry, I have to tell you, in my estimation, the FDA itself has violated its own federal [regulations].  In that situation, to me, this is an illegal approval, and the FDA is committing crimes.

— Dr. Jane Ruby

Compare the proposed Comirnaty package insert to inserts for other products, and the differences in quality of content become obvious.

Dr. Ruby then goes on to list some 20 alleged crimes that were committed just in the package insert.

Dr. Ruby offers a ray of hope: 50% of those inoculated received a placebo.

The ingredients list is due on September 7.

They had to ignore a whole lot to approve the inoculation.  This is not about health.

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]]> Senior FDA leaders stepping down https://pandemictimeline.com/2021/08/senior-fda-leaders-stepping-down/ Tue, 31 Aug 2021 00:00:52 +0000 https://pandemictimeline.com/?p=4697 Marion Gruber is the Signatory Authority listed on the Emergency Use Authorization. Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency in October and November, respectively, according to a letter shared with CNBC by FDA spokeswoman Stephanie Caccomo. A former senior FDA leader…

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]]> Marion Gruber is the Signatory Authority listed on the Emergency Use Authorization.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency in October and November, respectively, according to a letter shared with CNBC by FDA spokeswoman Stephanie Caccomo.

A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.

Much of the discord within the agency centers on the administration’s decision to push ahead with boosters before FDA’s top scientists had a chance to weigh in.

Their announced plans to depart come as the Biden administration prepares to begin offering Covid vaccine booster shots to the general public the week of Sept. 20.

Meanwhile, Paul Offit, a member of FDA’s vaccine advisory committee, stated of the booster plan that it was “the administration’s booster plan; it wasn’t the FDA’s booster plan. The administration has kind of backed themselves up against the wall a little bit here.”

The booster decision … was made by and announced by the nation’s leading public health officials, including Dr. Walensky, Dr. Fauci, Surgeon General Vivek Murthy, Dr. Janet Woodcock —the acting FDA commissioner —Dr. Francis Collins, Dr. Kessler and others. And as our medical experts laid out, having reviewed all the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.

“With 50% of its overall budget and 75% of its drug-testing budget coming from industry, the FDA long ago won its notoriety as the most corrupt and pliable of all federal agencies,” said Children’s Health Defense Chairman Robert F. Kennedy, Jr.

“Now, the White House has torn away its last shred of integrity by ordering top regulators to put politics before science.”

These FDA executives are upset because:

  • Biden said that boosters would be available September 20 without consulting them.
  • The CDC and its ACIP are making decisions that these executives believe belong to the FDA.
  • Their boss, Dr. Peter Marks, was not standing up to Biden and the CDC to protect the FDA’s authority.

There are indications that UK health officials are under pressure as well.  UK health officials are advising against jabs for children, but politicians are pressing forward anyway.

Both resigned FDA executive have since appeared as coauthors of an article in The Lancet.

Sources:

Related:

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]]> Dr. David Martin publishes document to send to your state attorney general https://pandemictimeline.com/2021/12/dr-david-martin-publishes-document-to-send-to-your-state-attorney-general/ Fri, 10 Dec 2021 00:00:27 +0000 https://pandemictimeline.com/?p=8556 Patrick:  You know, like I mentioned earlier, I think our last line of defense of, one of our last lines of defense are going to be the courts.  You know, we’ve got to get away from the executive brank.  You know, we’re very dysfunctional in our legislative branch.  But the courts, you know, shooting down…

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Patrick:  You know, like I mentioned earlier, I think our last line of defense of, one of our last lines of defense are going to be the courts.  You know, we’ve got to get away from the executive brank.  You know, we’re very dysfunctional in our legislative branch.  But the courts, you know, shooting down the mandate.  The Biden mandates, etcetera.  They think they are the last line of defense.  I’m always, you see the smile or chuckle as you’re quoting line and verse on these statutes.  You know, it’s like how you have all the stuff in your brain is amazing to me.  Is there a way that people can get access to the documents you described?

Dr. Martin:  Well, there you go.  I feel like I just entrapped you because I told you there is a thing.  It turns out if you go to either of my websites, FullyLiveAcademy.com, that’s Fully Live Academy, all one word.  FullyLiveAcademy.com or DavidMartin.world.  If you go to either of those two and click on the attorney general link, what you will get is actually the criminal indictment template, which has all eight felony counts that are actually listed right there.  And you can download those as I encourage people to do yesterday.  You can print them off.  You can send them certified mail to your U.S. Attorneys, to attorneys general in your state, to your elected officials in your state, to school boards, to anybody who’s doing a mandate and say you are now on notice of felony violations.  And guess what?  Like you just said, the courts are in fact going to ultimately deal with this issue.  And if you have gathered evidence in your own coercion, in your own manipulation of the things that have been foisted upon you, you will actually be part of the class that one day recovers those damages.  So I say, stand firm, inform yourself, get evidence, and take action.

Patrick:  I love it.

— Banned Video Archive

The document for your state attorney general is a request for prosecution.

These are the crimes that he claims have been committed:

These are the defendants suggested in the document:

Sources:

See also, on this site:

]]> FDA holds meetings regarding vaccines for 6-month-olds https://pandemictimeline.com/2022/06/fda-holds-meetings-regarding-vaccines-for-6-month-olds/ Tue, 14 Jun 2022 00:00:36 +0000 https://pandemictimeline.com/?p=10560 Do NOT jab your children! Those who jab their children are participating in a conspiracy against them the likes of which this world has not seen in recorded history.  These jabs are NOT vaccines in the normal sense.  These jabs contain gene modifying technology that can change your child’s DNA.  In addition, these jabs appear…

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Do NOT jab your children!

Those who jab their children are participating in a conspiracy against them the likes of which this world has not seen in recorded history.  These jabs are NOT vaccines in the normal sense.  These jabs contain gene modifying technology that can change your child’s DNA.  In addition, these jabs appear to contain nanotechnology intended to connect your children to the internet for tracking.  This can enslave them.  Furthermore, these jabs appear to have the capability of causing spiritual changes.  Jabbing your children could forever impair their intuition.  The overall death rate among children has greatly increased since they began jabbing them.

What you do to yourselves of your own free will is one thing; what you do to others, including your children, without their informed knowledge and consent is quite another matter.  Young children are not capable of giving informed consent, especially in a matter such as this.  It is the duty of parents and caregivers to protect them from harms.

COVID-19 does virtually no harm to children.  There is no need to jab them at all.

Luke 17:1-2 (NKJV)

1  Then He said to the disciples, “It is impossible that no offenses should come, but woe to him through whom they do come!
2  It would be better for him if a millstone were hung around his neck, and he were thrown into the sea, than that he should offendG4624 * one of these little ones.”

* See below for Strong’s analysis.

Those who have seen this warning cannot claim innocence before God.  You have been warned!

Those who find this warning after you have jabbed your kids, PRAY!  More on this below.

WE MUST MAKE EVERYONE AWARE OF THIS BEFORE PARENTS ALLOW THEIR CHILDREN TO BE INJECTED!!

  1. The most fundamental and required information needed to determine whether or not to approve a “vaccine” has NOT been provided by either Pfizer or Moderna.
  2. The Pfizer injections do NOT prevent death due to COVID-19.
  3. The first Pfizer injection actually increases the likelihood that babies will get COVID-19 by 29.7%.
  4. A full course of three Pfizer injections based on a manipulated Wuhan strain of SARS-CoV-2 have been shown to be only 14.5% effective in preventing COVID-19 in children 6-23 months old.
  5. Every child who received the placebo in the trials has survived. No babies in the placebo group died due to COVID-19. The study actually demonstrated that COVID-19 does NOT pose a risk of death to babies.
  6. Over 75% of children in the United States have been exposed to SARS-CoV-2 and have developed natural immunity. They do not need a “vaccine.”
  7. There is no emergency among young children and infants.
  8. There IS serious danger in these injections.

— James Roguski

Slide shown at 3:39:10 during the meeting

Note that the number of BNT162b2 test subjects reduce from 1027 to 277 over the course of the testing.  The number of Placebo test subjects reduce from 524 down to 139.

Why were so many participants withdrawn from the study? Where are the participants now?  How is their health?  Did they suffer adverse events that kept them from continuing with the study?

The FDA officials who might have wanted to stop the vaccine rollouts have already resigned, and we are left with those willing to keep pursuing the failed narrative in spite of the evidence of harm.

More on the warning above:

The following analyzes the source for the word “offend” as shown in Luke 17:1-2.  Note that the typical understanding of the verse is about hindering right conduct and causing the children to stumble into sin.  In the case of the jabs, its most literal connotation of entrapment is quite fitting as well.

G4624

σκανδαλίζω

skandalizō

skan-dal-id’-zo

To “scandalize”; from G4625; to entrap, that is, trip up (figuratively stumble [transitively] or entice to sin, apostasy or displeasure): – (make to) offend.

Total KJV occurrences: 30

skandalízō – properly, set a snare (“stumbling-block“); (figuratively) “to hinder right conduct or thought; to cause to stumble” – literally, “to fall into a trap” (Abbott-Smith). See 4625 (skandalon).

G4625

σκάνδαλον

skandalon

skan’-dal-on

A “scandal”; probably from a derivative of G2578; a trap stick (bent sapling), that is, snare (figuratively cause of displeasure or sin): – occasion to fall (of stumbling), offence, thing that offends, stumbling-block.

Total KJV occurrences: 15

skándalon – properly, the trigger of a trap (the mechanism closing a trap down on the unsuspecting victim); (figuratively) an offense, putting a negative cause-and-effect relationship into motion.

G2578

κάμπτω

kamptō

kamp’-to

Apparently a primary verb; to bend: – bow.

Total KJV occurrences: 4

Those who find this warning after you have jabbed your kids, PRAY!  At least one prophet has said that God can change DNA.  Some of the treatments mentioned on this site may mitigate some of the adverse effects of the jabs, but only God can repair the damage.

Matthew 19:26 (NKJV)

But Jesus looked at them and said to them, “With men this is impossible, but with God all things are possible.”

Mark 9:23 (NKJV)

Jesus said to him, “If you can believe, all things are possible to him who believes.”

1 John 5:14-15 (NKJV)

14  Now this is the confidence that we have in Him, that if we ask anything according to His will, He hears us.
15  And if we know that He hears us, whatever we ask, we know that we have the petitions that we have asked of Him.

James 4:2-3 (NKJV)

2  … Yet you do not have because you do not ask.
3  You ask and do not receive, because you ask amiss, that you may spend it on your pleasures.

Sources:

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]]> FDA refuses to provide autopsies https://pandemictimeline.com/2022/09/fda-refuses-to-provide-autopsies/ Thu, 29 Sep 2022 00:00:58 +0000 https://pandemictimeline.com/?p=11426 The refusal was issued to The Epoch Times, which submitted a Freedom of Information Act for all autopsy reported obtained by the FDA concerning any deaths reported to the Vaccine Adverse Event Reporting System following COVID-19 vaccination. … The FDA declined to release any reports, even redacted copies. … Kim Witczak, a drug safety advocate who…

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The refusal was issued to The Epoch Times, which submitted a Freedom of Information Act for all autopsy reported obtained by the FDA concerning any deaths reported to the Vaccine Adverse Event Reporting System following COVID-19 vaccination.

…

The FDA declined to release any reports, even redacted copies.

…

Kim Witczak, a drug safety advocate who advises the FDA as part of the Psychopharmacologic Drugs Advisory Committee, said that the reports could be released with personal information blacked out.

“The personal information could easily be redacted without losing the potential learnings from [the] autopsy,” Witczak told The Epoch Times via email.

— Zachary Stieber

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