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The United States Food and Drug Administration (FDA) has defined bioequivalence as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose ...
The Biosecurity Council of Western Australia was established on 27 February 2008 as a specialist advisory group to the Minister for Agriculture and Food and the Director-General of the Department of Primary Industries and Regional Development, [71] under the Biosecurity and Agriculture Management Act 2007 [72] (BAM Act).
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 Australian Drug Evaluation Committee (ADEC) was a committee that provided independent scientific advice to the Australian Government regarding therapeutic drugs.The committee was originally formed in 1963 and more recently authorised under the Therapeutic Goods Act 1989 (Cth) as part of the Therapeutic Goods Administration (TGA).
Drug-related authorities such as the European Medicines Agency (EMA) of the European Union, the United States Food and Drug Administration (FDA), and the Health Products and Food Branch of Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy.
Kessler was the commissioner of the Food and Drug Administration (FDA) from November 8, 1990, to February 28, 1997. He co-chaired the Biden-Harris transition’s COVID-19 Advisory Board from November 2020 to January 2021 and was the head of Operation Warp Speed , the U.S. government program to accelerate the development of COVID-19 vaccines and ...
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
In December 2010, purported lists of ingredients were published on the websites of Amazon.com and the Food and Drug Administration (FDA). [12] The list containing eight supposedly active ingredients of a liquid form of the drug were found in a 2002 document published on the FDA website [ 13 ] that contains correspondence between the FDA and a ...