Editing Food and Drug Administration (section)

===Vaccines, blood and tissue products, and biotechnology===
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[[File:Blood Research- Saving Lives (8352) (9759352093).jpg|thumb|FDA scientist prepares blood donation samples for testing.]]
The [[Center for Biologics Evaluation and Research]] is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents.<ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ |title=About the Center for Biologics Evaluation and Research (CBER) |publisher=Food and Drug Administration |date=March 2, 2017 |access-date=May 12, 2017 |archive-date=May 9, 2017 |archive-url=https://web.archive.org/web/20170509063921/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ |url-status=live}}.</ref><ref>{{Cite web |title=Center for Biologics Evaluation and Research |url=https://registries.ncats.nih.gov/glossary/center-for-biologics-evaluation-and-research/ |access-date=January 2, 2025 |website=RaDaR |language=en-US}}</ref> These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a [[Biologics license application|Biologics License Application]] (BLA), similar to that for drugs.

The original authority for government regulation of biological products was established by the 1902 [[Biologics Control Act]], with additional authority established by the 1944 [[Public Health Service Act]]. Along with these Acts, the [[Federal Food, Drug, and Cosmetic Act]] applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the [[National Institutes of Health]]; this authority was transferred to the FDA in 1972.