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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.
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 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 ...
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 ...
The amendment shifted the focus of regulation from the point of manufacturing to the point of sale, and adopted a risk-based classification system for products. [ 2 ] The June 2006 amendment to the law (Law No. 69 of 2006, with effective date of June 2009), represented the first change in the sales structure of OTC drugs in 46 years. [ 1 ]
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 ...
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]
Federal financial regulators are exploring allegations by two whistleblowers that Cash App, the popular mobile payment platform, and entities providing transaction services to its users performed ...