FDA Licensed Pfizer Vaccine Without Following Normal Approval Process, Documents Reveal

approved, control, quality

Zachary Stieber U.S. drug regulators acknowledged deviating from the normal vaccine approval process when dealing with Pfizer’s COVID-19 shot, according to newly disclosed documents. Weeks after Pfizer and its partner BioNTech announced they started a rolling submission of documents for approval of their COVID-19 vaccine, a U.S. Food and Drug Administration (FDA) official penned a […]

FDA Oversight of Clinical Trials is “Grossly Inadequate” Say Experts

Maryanne Demasi On 25 September 2020, the US Food and Drug Administration (FDA) received a complaint by Brook Jackson who had been working for Ventavia Research Group, a Texas based company hired to run clinical trials for Pfizer’s covid-19 mRNA vaccine. Jackson, a regional director, had witnessed problems at three trial sites she was overseeing […]

Gene-editing Therapy NTLA-2001 Given Orphan Drug Status by FDA

fapnewstoday.com The U.S. Food and Drug Administration (FDA) has given orphan drug designation to NTLA- 2001, an investigational gene-editing therapy for familial amyloid polyneuropathy (FAP) and other forms of transthyretin (ATTR) amyloidosis. … The aim of NTLA-2001 is to disrupt the TTR gene, thus decreasing transthyretin production and preventing the buildup of these harmful protein […]

FDA Refuses to Release Autopsy Results on People Who Died after COVID Vaccines

Zachary Steiber (The Epoch Times) 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 les, but a drug safety advocate says that it could release the autopsies with personal information redacted. […]