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The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. [4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).
An Australian Approved Name (AAN) is a generic drug name set by the Therapeutic Goods Administration (TGA) for use in Australia. [1] In late 2016, the TGA changed several drug names to the corresponding international nonproprietary name (INN), or, in cases where an INN was not available (as with asparaginase), another established generic name, such as the United States Adopted Name (USAN).
Schedule 9 (S9) drugs and poisons are substances and preparations that, by law, may only be used for research purposes. The sale, distribution, use, and manufacture of such substances without a permit is strictly prohibited by law. Permits for research uses on humans must be approved by a recognised ethics committee on human research. Examples ...
scFv: single-chain variable fragment. di-scFv: dimeric single-chain variable fragment. sdAb: single-domain antibody. BsAb: bispecific monoclonal antibody: 3funct: trifunctional antibody. BiTE: bi-specific T-cell engager. This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been ...
Dupilumab, sold under the brand name Dupixent, is a monoclonal antibody blocking interleukin 4 and interleukin 13, used for allergic diseases such as atopic dermatitis (eczema), asthma and nasal polyps which result in chronic sinusitis. [6][7][8][4] It is also used for the treatment of eosinophilic esophagitis, [9] prurigo nodularis [10] and ...
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The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be ...
The Biden administration on Wednesday said it will impose inflation penalties on 64 prescription drugs for the third quarter of this year, lowering costs for certain older Americans enrolled in ...