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Tag: FDA (U.S. Food and Drug Administration)

The Food and Drug Administration is part of the Department of Health and Human Services and is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

Sharp Rise in Marijuana-Related Psychosis: American Board of Pain Medicine President
Posted inNational News

Sharp Rise in Marijuana-Related Psychosis: American Board of Pain Medicine President

Avatarby USNN2020October 9, 2022March 1, 2025
Nearly 50 new government defendants have been added to the lawsuit that alleges the government induced censorship of state officials and others on social media. The second amended complaint in the case, Missouri v. Biden, includes six new agencies, bringing the total to 13, and 41 new individual defendants, bringing the total to 54. Altogether, 67 officials or agencies are accused of violating plaintiffs’ First Amendment rights by participating in a “censorship enterprise” through pressuring Big Tech firms like Facebook, Google, and Twitter to take action against users offering alleged misinformation. Evidence backing the claims has been produced in discovery, including exchanges between White House officials and Meta, Facebook’s parent company and messages showing meetings between administration officials and the firms. The new defendants include the FBI; former White House senior COVID-19 adviser Andrew Slavitt; Dana Remus, counsel to President Joe Biden; Elvis Chan, an FBI special agent based in San Francisco; Janell Muhammed, deputy digital director at the Department of Health and Human Services; Allison Snell, an official at the Cybersecurity and Infrastructure Security Agency; the Food and Drug Administration (FDA); the State Department; and Mark Robbins, interim executive director of the U.S. Election Assistance Commission. One or more of the Big Tech firms that were subpoenaed in the case identified the officials as possibly communicating with them on content moderation relating to “COVID-19 misinformation,” the New York Post’s story about Hunter Biden’s laptop, the administration’s since-disbanded Disinformation Governance Board, and/or “election security, integrity, outcomes, and/or public confidence in election outcomes (not to include issues of foreign interference or related issues).” Slavitt was named because emails show he was in communication with Facebook regarding the combating of alleged misinformation. The messages show that Facebook was committed to censoring and de-emphasizing posts that were “departing from the government’s messaging on vaccines,” plaintiffs said. Slavitt also called for Twitter to ban Alex Berenson, an independent journalist, previously released messages show. Muhammed, meanwhile, was in touch with Facebook to ask the company to take down pages and accounts that were allegedly misrepresenting themselves as representing the government. “Absolutely,” one of the Facebook employees responded. Other discovery suggests the FDA “has participated in federally-induced censorship of private speech on social media about questions of vaccine safety and efficacy, among other subjects,” plaintiffs said. The agencies that were added to the case did not respond to requests for comment. U.S. District Judge Terry Doughty, a Trump appointee overseeing the case, recently ordered defendants named in earlier complaints to comply with demands, including Dr. Anthony Fauci, a top medical adviser to Biden. The new documents do not include any more information from Fauci or the White House press secretary’s office.
Posted inNational News

47 New Biden Administration Defendants Named in Government–Big Tech Censorship Lawsuit

Avatarby USNN2020October 7, 2022December 28, 2024
US Buys $290 Million Worth of Drugs in Preparation for Nuclear Emergencies
Posted inNational News

US Buys $290 Million Worth of Drugs in Preparation for Nuclear Emergencies

Avatarby USNN2020October 7, 2022August 26, 2024
FDA Preparing to Publish Study on 4 Potential Adverse Events Following Pfizer Vaccination
Posted inHealthcare

FDA Preparing to Publish Study on 4 Potential Adverse Events Following Pfizer Vaccination

Avatarby USNN2020October 2, 2022April 30, 2024
FDA Withholding COVID-19 Vaccine Safety Data is Illegal: Lawmakers
Posted inNational News

FDA Withholding COVID-19 Vaccine Safety Data is Illegal: Lawmakers

Avatarby USNN2020October 1, 2022March 18, 2024
The U.S. Food and Drug Administration (FDA) is refusing to release the results of autopsies conducted on people who died after getting COVID-19 vaccines. The FDA says it is barred from releasing medical files, but a drug safety advocate says that it could release the autopsies with personal information redacted. 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. Reports are lodged with the system when a person experiences an adverse event, or a health issue, after receiving a vaccine. The FDA and other agencies are tasked with investigating the reports. Authorities request and review medical records to vet the reports, including autopsies. The FDA declined to release any reports, even redacted copies. The FDA cited federal law, which enables agencies to withhold information if the agency “reasonably foresees that disclosure would harm an interest protected by an exemption,” with the exemption being “personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.” Federal regulations also bar the release of “personnel, medical and similar files the disclosure of which constitutes a clearly unwarranted invasion of personal privacy.” The Epoch Times has appealed the denial, in addition to the recent denial of results of data analysis of VAERS reports. ‘Easily Be Redacted’ 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. People make the choice to submit autopsy results to the Vaccine Adverse Event Reporting System, Witczak noted. “If someone submits their experience to VAERS they want and expect to have it investigated by the FDA. This includes autopsy reports,” she said. Autopsies are examinations of deceased persons performed to determine the cause of death. “Autopsies can be an important part of postmortem analysis and should be done especially with increased deaths following COVID-19 vaccination,” Witczak said. FDA Responds An FDA spokesperson noted that deaths following COVID-19 vaccination are rare, citing the number of reports made to VAERS. As of Sept. 14, 16,516 reports of death following COVID-19 vaccination have been reported. Approximately 616 million doses have been administered in the United States through September. The spokesperson declined to say whether the FDA would ever release the autopsy results, but pointed to a paper authored by researchers with the FDA and the Centers for Disease Control and Prevention (CDC). The paper, which has not been peer reviewed, analyzed the approximately 9,800 reports of death to VAERS following COVID-19 vaccination lodged from Dec. 14, 2020, to Nov. 17, 2021. Researchers found that reporting rates were lower than the expected all-cause mortality rates. “Trends in reporting rates reflected known trends in background mortality rates. These findings do not suggest an association between vaccination and overall increased mortality,” the researchers wrote. The researchers noted that prior studies have found that adverse events reported to VAERS are an undercount of the true number of events.
Posted inHealthcare

FDA Withholding Autopsy Results on People Who Died After Getting COVID-19 Vaccines

Avatarby USNN2020September 30, 2022March 18, 2024
Why Does the Omicron Booster Contain the Wuhan Strain? No, It’s Not for Higher Protection
Posted inHealthcare

Why Does the Omicron Booster Contain the Wuhan Strain? No, It’s Not for Higher Protection

Avatarby USNN2020September 17, 2022June 30, 2024
Vaccinated at Higher Risk of Serious Adverse Events: Reanalysis of Original Trial Data
Posted inHealthcare

Vaccinated at Higher Risk of Serious Adverse Events: Reanalysis of Original Trial Data

Avatarby USNN2020September 2, 2022September 3, 2022
Drastic Increase in Non-Infectious Diseases in Military Explained as Data Glitch: Whistleblower
Posted inNational News

Drastic Increase in Non-Infectious Diseases in Military Explained as Data Glitch: Whistleblower

Avatarby USNN2020August 23, 2022February 23, 2025
White House Health Official Makes False Claim About COVID-19 Vaccines
Posted inHealthcare

White House Health Official Makes False Claim About COVID-19 Vaccines

Avatarby USNN2020June 20, 2022July 1, 2025
Cancer Trial Using Monoclonal Antibody Finds Remission in Every Patient: Report
Posted inNational News

Cancer Trial Using Monoclonal Antibody Finds Remission in Every Patient: Report

Avatarby USNN2020June 6, 2022June 1, 2025
Five GOP Senators Seek Info From NIH Acting Director on Royalty Payments to Feds
Posted inNational News

Five GOP Senators Seek Info From NIH Acting Director on Royalty Payments to Feds

Avatarby USNN2020June 1, 2022February 17, 2025

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