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The California Department of Food and Agriculture (CDFA) is a cabinet-level agency in the government of California.Established in 1919 by the California State Legislature and signed into law by Governor William Stephens, the Department of Food and Agriculture is responsible for ensuring the state's food safety, the protection of the state's agriculture from invasive species, and promoting the ...
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The Bureau was transferred from the NIH to the FDA in 1972, where it was renamed Bureau of Biologics and focused on vaccines, serums for allergy shots, and blood products. [ 8 ] Ten years later, with the beginning of the biotechnology revolution , the line between a drug and a biologic, or a device and a biologic, became blurred. [ 8 ]
The FDA has had the responsibility of reviewing drugs since the passage of the 1906 Pure Food and Drugs Act. The 1938 Federal Food, Drug and Cosmetic Act required all new drugs to be tested before marketing by submitting the original form of the new drug application. Within the first year, the FDA's Drug Division, the predecessor to CDER ...
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