Introduction There are some adverse reactions in a product label that are so serious, and possibly even preventable, that special labeling is required to highlight this warning information: a “BOXED WARNING.” https://www.fda.gov/media/71866/download https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.57 This boxed warning information, “critical for a prescriber to consider,” is commonly referred to as a […]
Letter to the FDA: COVID-19 ‘Vaccines’ and COVID-19 Infection Linked to Myocarditis – What Do They Have in Common?
Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research U.S. Food and Drug Administration 10903 New Hampshire Avenue WO71-7232 Silver Spring, MD 20993 Peter.Marks@fda.hhs.gov December 18, 2022 Dear Dr. Marks, I am troubled by the following, and look forward to your studied response on my single […]