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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).
Over-the-counter (OTC) drug (Obat bebas), drugs freely available to the public. Marked by green circle with black line. Limited OTC drug (Obat bebas terbatas), drugs available to the public only through pharmacy (apotek) or licensed drug stores. Marked by blue circle with black line. Prescription drug (Obat keras), prescription only medicine ...
The idea is that countries with non-SRA drug authorities can use accelerated process to facilitate approval (registration or marketing authorization) of medicines, including vaccines and biologics, which have already been approved by SRAs. [1] As of 2022, the national regulatory authorities of 36 countries are considered SRAs: [2]
The Medicare drug list, also called a formulary, lists the prescription drugs and vaccines that Medicare covers. Medicare provides this coverage through Medicare Part D or Medicare Advantage (also ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
(Reuters) -The U.S. Food and Drug Administration on Monday delayed traditional approval for Liquidia Corp's inhaled drug for types of lung disorders, and allowed only tentative clearances, sending ...
The treatment, Tivdak - an antibody-drug conjugate co-developed by Genmab A/S and Seagen - received the FDA's accelerated approval for the same indication in 2021. It was added to Pfizer's ...