Newsletter - August 27, 2020
FDA has for Forever Tainted Plasma Treatment for COVID with Bad Politics
FDA’s decision this week to formally authorize COVID-19 convalescent plasma (CCP) as a treatment for COVID-19 was immediately panned almost universally as a politicized action by FDA. It did not help that the authorization was announced more like a campaign event than a regulatory milestone, with misleading statements...Read More
HHS Clarifies that FDA Cannot Regulate LDTs
The Department of Health and Human Services (HHS), the governing body over the FDA, rescinded FDA’s guidance documents regarding the need for pre-market approval or emergency use authorization for Laboratory Developed diagnostic tests (LDTs). LDTs are widely used and have been in a regulatory limbo for many years ....Read More
FDA has for Forever Tainted Plasma Treatment for COVID with Bad Politics
FDA’s decision this week to formally authorize COVID-19 convalescent plasma (CCP) as a treatment for COVID-19 was immediately panned almost universally as a politicized action by FDA. It did not help that the authorization was announced more like a campaign event than a regulatory milestone, with misleading statements...Read More
HHS Clarifies that FDA Cannot Regulate LDTs
The Department of Health and Human Services (HHS), the governing body over the FDA, rescinded FDA’s guidance documents regarding the need for pre-market approval or emergency use authorization for Laboratory Developed diagnostic tests (LDTs). LDTs are widely used and have been in a regulatory limbo for many years ....Read More
