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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.
Medical foods are regulated by the US Food and Drug Administration under the Food Drug and Cosmetic Act regulations. 21 CFR 101.9(j) (8). [1]The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Food poisoning, also known as foodborne illness, is a common sickness caused by swallowing food or liquids that contain harmful bacteria, viruses or parasites, and sometimes even chemicals.
HU 260 EK Where HU is the country code for Hungary, 260 is the national approval number of a processing facility (in this case, a dairy facility of the company Alföldi Tej), and EK stands for Európai Közösség (European Community in Hungarian). Another example with a more complex national approval number: FR 49.099.001 CE Where FR is the country code for France, 49.099.001 is a complex ...
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The main discussion of these abbreviations in the context of drug prescriptions and other medical prescriptions is at List of abbreviations used in medical prescriptions. Some of these abbreviations are best not used, as marked and explained here.
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