A group of doctors is urging a U.S. court to block the Food and Drug Administration (FDA) from issuing guidance on using ivermectin, in an appeal lodged after a district court judge rejected their bid. The FDA “cannot advise whether or for what purpose a doctor should prescribe, or a patient should take, an approved…
Doctors Appeal Ruling in Favor of FDA Over Ivermectin Posts, Urge Court to Intervene
FDA Finds Dirty Equipment and Lack of Safeguards at Eye Drops Factory Amid Deadly Outbreak
U.S. inspectors found dirty equipment and other issues at an eye drops factory as officials investigate a serious outbreak of bacterial infections, some of which have led to deaths. U.S. Food and Drug Administration (FDA) inspectors saw “black, brown colored greasy deposit” on one machine and found the machine had not been cleaned for weeks,…
FDA Finds Dirty Equipment, Lack of Safeguards at Eye Drops Factory Amid Deadly Outbreak
U.S. inspectors found dirty equipment and other issues at an eye drops factory as officials investigate a serious outbreak of bacterial infections, some of which have led to deaths. U.S. Food and Drug Administration (FDA) inspectors saw a “black, brown colored greasy deposit” on one machine and found that the machine hadn’t been cleaned for…
CDC, FDA Respond to Florida Surgeon General’s COVID-19 Vaccine Safety Alert
March 14, 2023
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U.S. health authorities have responded to the warning from Florida’s surgeon general about a spike in reports of adverse events following COVID-19 vaccination. Drs. Rochelle Walensky and Robert Califf claimed in the response that Dr. Joseph Ladapo, the Sunshine State’s surgeon general, was misleading the public by focusing on the increase in adverse events reported…
FDA Officials Push Back After Adviser Says Young, Healthy People Don’t Need New COVID-19 Boosters
March 2, 2023
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Top U.S. Food and Drug Administration (FDA) officials are countering an adviser’s position that young, healthy people do not need the updated COVID-19 vaccine boosters. Drs. Robert Califf and Peter Marks pointed to a study that analyzed the immune response from 12 people after receiving one of the updated boosters, compared with 23 people who…
FDA Reveals Why It Changed End Date of Study Examining Heart Inflammation After Pfizer COVID Vaccination
February 14, 2023
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The U.S. Food and Drug Administration (FDA) changed the end date of a study it is requiring Pfizer to conduct because Pfizer requested a delay, the agency says. “The company requested an extension from FDA for completion, which the agency granted,” an FDA spokesperson told The Epoch Times via email. When the FDA approved Pfizer’s…
FDA Reveals Why It Changed End Date of Study of Heart Inflammation After COVID Vaccination
February 14, 2023
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The U.S. Food and Drug Administration (FDA) changed the end date of a study it is requiring Pfizer to conduct because Pfizer requested a delay, the agency says. “The company requested an extension from FDA for completion, which the agency granted,” an FDA spokesperson told The Epoch Times via email. When the FDA approved Pfizer’s…
Experts Want Labels for Pfizer, Moderna COVID-19 Vaccines Updated to Acknowledge Limitations
A coalition of experts is calling for U.S. officials to update the labels for the Pfizer and Moderna COVID-19 vaccines to acknowledge limitations to clinical trials, including stating clearly that the phase III trials that led to clearance did not provide evidence of efficacy against death. “Incomplete, inaccurate, or misleading labeling of any medical product…
COVID Vaccine Package Labels ‘Severely Outdated’: Coalition of Health Experts Petition FDA to Update
A health expert coalition published a citizen petition on Jan. 31 requesting the U.S. Food and Drug Administration (FDA) to update COVID-19 vaccine package labels with the most recent data on safety and efficacy. In the filed petition, coalition members argued that the labels are outdated; recent safety and efficacy clinical data have not been…
FDA Sued for Withholding COVID-19 Vaccine Safety Analyses
January 28, 2023
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The U.S. Food and Drug Administration (FDA) has been sued for withholding the results of key COVID-19 vaccine safety analyses. The FDA’s actions violate federal law, the new lawsuit, filed on Jan. 26 in federal court in Washington by the nonprofit Children’s Health Defense (CHD), alleges. The suit is seeking the raw results from the…
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