Category: FDA

Live Q&A: OSHA Suspends Biden Vaccine Mandate; FDA Wants 55 Years to Release Vaccine Approval Data

The Labor Department’s Occupational Safety and Health Administration (OSHA) announced it has suspended the Biden vaccine mandate for COVID-19 in both implementation and enforcement for businesses with 100 or more employees. And in other news, the Food and Drug Administration (FDA) is asking a court for 55 years to release information on its approval for…


Facts Matter (Nov. 18): Lawsuit Reveals that FDA Wants 55 Years to Fully Release Pfizer Vaccine Data

The FDA recently made an official request to a federal judge, asking whether it can take 55 years to fully release all of the documents pertaining to the approval of the Pfizer vaccine—meaning that if this request is approved, we won’t be able to see all of the documents until 2076. As this is taking…


Deep Dive (Nov. 18): ‘Tragic’: Biden on 100,000 Overdose Deaths Stats

New federal data suggests America’s drug epidemic has reached its deadliest height. The CDC published new data showing overdose deaths have topped 100,000 annually for the first time. President Joe Biden called it “a tragic milestone.” Researchers say the new record is being driven by opioid abuse. Synthetic opioids, primarily fentanyl, caused nearly two-thirds of all…


FDA Asks Court for 55 Years to Fully Release Pfizer COVID-19 Vaccine Data

The Food and Drug Administration (FDA) asked a federal judge on Nov. 15 to give it until the year 2076 to fully release the documents in its possession tied to the approval of the Pfizer-BioNTech COVID-19 vaccine. The FDA’s request was made in a filing as part of a Freedom of Information Act (FOIA) lawsuit…


Moderna Asks FDA to Authorize COVID-19 Vaccine Boosters for All Adults

Moderna on Wednesday asked U.S. drug regulators to widen authorization for additional doses of its COVID-19 vaccine. The Massachusetts-based biotechnology firm wants every American 18 or older to be able to get a booster. The Food and Drug Administration (FDA) recently allowed boosters of the Moderna and Pfizer COVID-19 vaccines, which both have two-shot primary…


FDA to Decide on Pfizer Booster Shots Without Hearing From Expert Panel That Rejected Earlier Bid

U.S. drug regulators will decide whether to greenlight booster doses of Pfizer’s COVID-19 vaccine for all Americans 16 or older without convening its expert vaccine advisory panel, the Food and Drug Administration (FDA) confirmed to The Epoch Times on Wednesday. FDA’s acting head and other top Biden administration officials said earlier this year that booster…


FDA to Decide on Pfizer Booster Shots Without Hearing From Expert Panel

U.S. drug regulators will decide whether to greenlight booster doses of Pfizer’s COVID-19 vaccine for all Americans 16 or older without convening its expert vaccine advisory panel, the Food and Drug Administration (FDA) confirmed to The Epoch Times on Wednesday. FDA’s acting head and other top Biden administration officials said earlier this year that booster…


FDA to Decide on Pfizer Vaccine Booster Shots Without Hearing From Expert Panel

U.S. drug regulators will decide whether to approve booster doses of Pfizer’s COVID-19 vaccine for all Americans aged 16 or older without convening its expert vaccine advisory panel, the Food and Drug Administration (FDA) confirmed to The Epoch Times on Nov. 17. The FDA’s acting head and other top Biden administration officials said earlier in…


US FDA Authorizes Virtual Reality System for Reducing Back Pain

The U.S. Food and Drug Administration on Tuesday authorized a virtual reality (VR) system from Applied VR for reducing lower back pain after a majority of patients in a trial testing the device showed lesser discomfort. The device, EaseVRx, uses cognitive behavioral therapy and other associated methods to help with pain reduction and is meant…


Pfizer Board Member: CDC Has ‘Confusing’ COVID-19 Booster Messaging

Pfizer board member and former Food and Drug Administration head Scott Gottlieb said federal health officials’ messaging on COVID-19 booster doses is generally unclear. The “confusing messaging” from the Centers for Disease Control and Prevention (CDC) regarding COVID-19 booster shots “may end up being one of the biggest missed opportunities in this pandemic,” Gottlieb told CBS…