The Food and Drug Administration’s request for 75 years before it fully releases information on how it approved the Pfizer COVID-19 vaccine has been shot down by a federal judge. The FDA now has just over 8 months to provide these documents for public review. U.S. District Judge Mark Pittman ordered the FDA to produce…
Live Q&A: Judge Refuses FDA Request, Gives 8 Months for Pfizer Data; Trump Social Network Nears
January 9, 2022
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Facts Matter (Jan. 7): Rejects FDA Request, Gives Agency 8 Months to Produce Pfizer’s Safety Data
After several months of legal back-and-forth in the courtroom, with the FDA requesting up to 75 years to release all of their vaccine safety-related documents, a federal court has just ruled against them. Instead, that judge said the FDA has only eight months to release all of their Pfizer vaccine safety data—meaning that we might…
Judge Gives FDA Just Over 8 Months to Produce Pfizer’s Safety Data
January 6, 2022
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A federal judge on Thursday ordered the U.S. Food and Drug administration to produce the documents it’s relied on to license the Pfizer-BioNTech COVID-19 vaccine, at a rate of 55,000 pages a month. The rate of 55,000 pages a month would mean the FDA has just over eight months to fully produce all of Pfizer’s pre-licensure safety…
CDC Announces Move to Shorten Waiting Period for Pfizer COVID-19 Boosters
The U.S. Centers for Disease Control and Prevention (CDC) on Tuesday backed the Food and Drug Administration’s (FDA) decision to offer COVID-19 booster doses after five months, rather than six months. The recommendation applies to the Pfizer-BioNTech mRNA vaccine, according to the agency. The CDC still suggests that the Moderna and Johnson & Johnson recipients get their…
FDA Authorizes Pfizer’s COVID-19 Vaccine Booster for Children 12–15
The U.S. Food and Drug Administration (FDA) on Monday authorized a booster shot of Pfizer’s COVID-19 vaccine for children 12 to 15. The agency said that its scientists determined the booster’s benefits, including bolstering protection against virus infection, outweigh its potential risks in the population. Reviewers analyzed data from Israel, one of the most vaccinated countries…
FDA Authorizes Pfizer’s COVID-19 Vaccine Booster for Children 12 to 15
The U.S. Food and Drug Administration (FDA) on Jan. 3 authorized a booster shot of Pfizer’s COVID-19 vaccine for 12- to 15-year-olds. The agency stated that its scientists determined the booster’s benefits, including bolstering protection against virus infection, outweigh its potential risks in the population. Reviewers analyzed data from Israel, one of the most vaccinated countries…
US Authorizes German Firm Siemens Healthineers’ At-home COVID-19 Test
December 30, 2021
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The U.S. drug regulator has granted emergency use authorization to German health technology company Siemens Healthineers’ at-home COVID-19 tests, a move that will boost availability of tests pressured by rising infection cases. The approval comes at a time when companies such as Walmart Inc., Walgreens Boots Alliance, and CVS Health Corp. have limited sales of…
FDA: Rapid COVID-19 Tests May Be Less Accurate for Omicron Variant
The U.S. Food and Drug Administration (FDA) said rapid COVID-19 tests could be less accurate when trying to detect the new Omicron variant. Rapid tests, including the very commonly used antigen tests, can detect the Omicron variant “but may have reduced sensitivity,” the FDA said in a statement on Dec. 28. The FDA’s findings regarding…
Roche Says At-home COVID-19 Rapid Test Gets Ok From FDA
Roche said on Friday that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to its COVID-19 at-home rapid test that can be used by people as young as 14. The test, which uses an anterior nasal swab sample, is “able to produce accurate, reliable and quick results in as few…
Biogen, Eisai Alzheimer’s Drug Lecanemab Gets ‘Fast Track’ Designation From FDA
Biogen Inc. and Japanese partner Eisai Co. said on Thursday the U.S. Food and Drug Administration (FDA) had granted “fast track” designation to their experimental therapy lecanemab for the treatment of early Alzheimer’s disease. The FDA had granted “breakthrough” therapy designation to the drug earlier this year. The drug works in a similar manner to…
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