Tag: Food and Drug Administration

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

October 2, 2022
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U.S. Food and Drug Administration (FDA) researchers are preparing to publish a study on a set of data that identified four potential issues in elderly persons after COVID-19 vaccination. The FDA announced in July 2021 that near real-time surveillance detected four potential adverse events of interest following receipt of Pfizer’s vaccine. The agency has given zero…

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

October 1, 2022
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Rep. Gregory Steube (R-Fla.) and other U.S. lawmakers are asserting that the Food and Drug Administration’s (FDA) refusal to provide records to The Epoch Times is illegal. The Freedom of Information Act (FOIA) states that, with exceptions, agencies that receive satisfactory records requests “shall make the records promptly available” to the requester. But the FDA…

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

September 29, 2022
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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…

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EXCLUSIVE: FDA Refuses to Provide Key COVID-19 Vaccine Safety Analyses

September 10, 2022
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U.S. drug regulators are refusing to provide key analyses of a COVID-19 vaccine safety database, claiming that the factual findings cannot be separated by internal discussions protected by law. The Epoch Times asked the Food and Drug Administration (FDA) in July for all analyses performed by the agency for the COVID-19 vaccines using a method…

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LIVE NOW: NY to Make Churches, Other Places Gun-Free Zones; DeSantis Sues FDA Over Low-Cost Drug Issue | NTD Evening News

August 31, 2022
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New York’s Concealed Carry Improvement Act will take effect on Sept. 1, effectively making Times Square and many other locations “gun-free zones.” Florida Gov. Ron DeSantis says he is suing the Food and Drug Administration. He accuses it of preventing Floridians from getting lower-priced medicine. * Click the “Save” button below the video to access…

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NY to Make Churches, Other Places Gun-Free Zones; DeSantis Sues FDA Over Low-Cost Drug Issue | NTD Evening News

August 31, 2022
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New York’s Concealed Carry Improvement Act will take effect on Sept. 1, effectively making Times Square and many other locations “gun-free zones.” Florida Gov. Ron DeSantis says he is suing the Food and Drug Administration. He accuses it of preventing Floridians from getting lower-priced medicine. * Click the “Save” button below the video to access…

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Bluebird’s $2.8 Million Gene Therapy Becomes Most Expensive Drug After US Approval

August 19, 2022
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The U.S. Food and Drug Administration on Wednesday approved bluebird bio’s gene therapy for patients with a rare disorder requiring regular blood transfusions, and the drugmaker priced it at a record $2.8 million. The approval sent the company’s shares 8 percent higher and is for the treatment of beta-thalassemia, which causes an oxygen shortage in…

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The Rise and Fall of E-cigarettes

August 16, 2022
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Electronic cigarettes (e-cigarettes), better known as vapes, seem to be on the path of decline. After a series of regulations and market takedowns by the Food and Drug Administration (FDA), media reports of adverse effects, and lobbying by legislators and health advocates, the demand for e-cigarettes has fallen. In July 2022, FDA banned JUUL products,…

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FDA Rejects Request to Revoke Emergency Authorization of Pfizer’s Vaccine for Some Children

July 30, 2022
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U.S. drug regulators have rejected a request to revoke emergency authorization for Pfizer’s COVID-19 vaccine for 12- to 15-year-olds. “Petitioner has provided no basis to demonstrate that the EUA should be revoked,” Dr. Peter Marks, a top Food and Drug Administration (FDA) official, wrote in a June 17 letter, which was made public on July…

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Top FDA Officials Concerned About Pressure to Authorize COVID-19 Vaccine Boosters: Emails

July 29, 2022
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Top officials at the U.S. Food and Drug Administration (FDA) were worried about what they saw as pressure being placed on them by vaccine companies and the White House to clear booster shots, according to newly released emails. Dr. Marion Gruber, the director of the FDA’s Office of Vaccines Research and Review (OVRR), said that she…

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