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The Health Sciences Authority headquarters at Outram Road, Singapore. HSA was formed on 1 April 2001 with the integration of five specialised agencies under the Ministry of Health: the Centre for Drug Evaluation; Institute of Science and Forensic Medicine; National Pharmaceutical Administration; Product Regulation Department; and Singapore Blood Transfusion Service.
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 ...
Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products ( generic drugs ).
The MHRA has several independent advisory committees which provide the UK Government with information and guidance on the regulation of medicines and medical devices. There are currently eight such committees: [citation needed] Advisory Board on the Registration of Homeopathic Products; Herbal Medicines Advisory Committee; The Review Panel
United Therapeutics alleged that Liquidia skirted long standing FDA rules, precedents and procedures when it filed its application for an inhaled dry powder of treprostinil for pulmonary ...
Pharmacy and Therapeutics (P&T) is a committee at a hospital or a health insurance plan that decides which drugs will appear on that entity's drug formulary.The committee usually consists of healthcare providers involved in prescribing, dispensing, and administering medications, as well as administrators who evaluate medication use. [1]
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).
Pharmaceutical Drugs Directorate (PDD), previously called the Therapeutic Products Directorate (TPD), is a Canadian federal authority that regulates small molecule pharmaceutical drugs for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy , and ...