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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 Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century.
Signed into law by President George H. W. Bush on October 29, 1992. The Prescription Drug User Fee Act ( PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to ...
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common ...
Food and Drug Administration. / 39.03528°N 76.98306°W / 39.03528; -76.98306. 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 ...
The Multistate Pharmacy Jurisprudence Examination ( MPJE) is a pharmacy law examination created by the National Association of Boards of Pharmacy (NABP) in the United States to help individual state boards of pharmacy assess the competency and knowledge of pharmacy law. [1] It is required as a prerequisite for a pharmacy license by 48 states ...
Gov. Phil Murphy signed a compromise measure that will reform liquor license laws in New Jersey. But the governor says there is more work still to do. New NJ liquor license law is 'revolutionary ...
A restaurant in New Jersey without a liquor license can sell wine from a New Jersey winery by becoming an offsite retail sales outlet of the winery. Since the early 1990s, there have been a handful of unsuccessful proposals to create a separate restaurant license allowing eating establishments to sell beer and wine.