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The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of biological products such as vaccines in the United States. [1] It was enacted in response to two incidents involving the deaths of 22 children who had contracted tetanus from contaminated vaccines . [ 2 ]
This incident, and a similar one involving contaminated smallpox vaccine in Camden, New Jersey, led to the passage of the Biologics Control Act of 1902, which established the Center for Biologics Evaluation and Research.
The 1902 Biologics Control Act was put in place after diphtheria antitoxin was collected from a horse named Jim who contracted tetanus, resulting in several deaths. Much credit is given to the deaths of many people in the 1930s, including Eben Byers in 1932 from the ingestion of radithor and many women, some known as The Radium Girls , to ...
New biologics are required to go through a premarket approval process called a 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.
21st Century Cures Act, PL 114–255 (December 13, 2016) [39] [40] [41] FDA Reauthorization Act of 2017, PL 115–52 (August 18, 2017) [42] Other laws: [43] Biologics Control Act of 1902 (repealed; for historical reference) Federal Food and Drugs Act of 1906 (repealed; for historical reference) Federal Meat Inspection Act (March 4, 1907)
The Biologics Control Act of 1902 required that federal government grant premarket approval for every biological drug and for the process and facility producing such drugs. This was followed in 1906 by the Pure Food and Drugs Act, which forbade the interstate distribution of adulterated or misbranded foods and drugs. A drug was considered ...
The latest Biosecure Act also adds WuXi Biologics to a list of biotech companies of concern, according to a copy seen by Reuters. The other companies on the list are BGI, MGI, Complete Genomics ...
The 1901 diphtheria antitoxin contamination incident, in which the milk wagon horse used to culture the antitoxin became infected with tetanus, which contaminated vials of the antitoxin leading to the deaths of several children in the midwest United States, [5] led to the passage of the Biologics Control Act of 1902 and the 1906 formation of ...