FDA Doesn't Test Vaccines

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FDA Doesn't Test Vaccines

Testing is Responsibility of Manufacturer Only

http://www.fda.gov/drugs/special-features/frequently-asked-questions-about-fda-drug-approval-process

Frequently Asked Questions about the FDA Drug Approval Process

"Q: Does FDA test drugs?

A: No. It is the responsibility of the company seeking approval to market a drug to conduct laboratory and animal tests on the safety and effectiveness of a proposed new drug and then to submit that information to FDA for review by CDER physicians, statisticians, chemists, pharmacologists, and other scientist."

FDA Removed Inspection Requirements

for Vaccines in 2019

https://www.federalregister.gov/documents/2019/04/02/2019-06187/removal-of-certain-time-of-inspection-and-duties-of-inspector-regulations-for-biological-products

"Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products*

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements."

* "Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins."

https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers