Newsletter - September 14, 2023
The Covid Boosters in the Post-Pandemic Age: Would Covid Be the New Flu?
The FDA approval and the CDC endorsement of the latest Covid booster vaccines were received with a generally lukewarm reception. The CDC, FDA, and other government agencies presented the Covid booster vaccines as akin to the annual flu vaccine having followed a process to identify the prevailing strains of...Read More
FDA’s Clarifies its Expectations from IRB Review of Compassionate Use
Emergency use or compassionate use protocols rely heavily on IRB review of such use of an investigational product. Individual patients in life-threatening conditions can be treated without prior approval by the FDA or an IRB with the expectation that the physician using an investigational treatment on his/her patient would inform...Read More
The Covid Boosters in the Post-Pandemic Age: Would Covid Be the New Flu?
The FDA approval and the CDC endorsement of the latest Covid booster vaccines were received with a generally lukewarm reception. The CDC, FDA, and other government agencies presented the Covid booster vaccines as akin to the annual flu vaccine having followed a process to identify the prevailing strains of...Read More
FDA’s Clarifies its Expectations from IRB Review of Compassionate Use
Emergency use or compassionate use protocols rely heavily on IRB review of such use of an investigational product. Individual patients in life-threatening conditions can be treated without prior approval by the FDA or an IRB with the expectation that the physician using an investigational treatment on his/her patient would inform...Read More
