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The Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals, more commonly known by its abbreviation CPS, [1] is a reference book that contains drug monographs and numerous features which help healthcare professionals prescribe and use drugs safely and appropriately.
A drug product sold in Canada without a DIN is not in compliance with Canadian law, with limited exceptions, such as foreign drug products imported under emergency authorization. [2] [3] The DIN is also a tool to help in the follow-up of products on the market, recall of products, inspections, and quality monitoring.
In 1989, the CDA's predecessor, the Canadian Coordinating Office for Health Technology Assessment (CCOHTA), was created by the federal government in response to this challenge. [ 1 ] [ 5 ] In 2006, the organization became the Canadian Agency for Drugs and Technologies in Health (CADTH).
The EUND pathway was developed to allow a mechanism for authorization of these drugs based on non-clinical and limited clinical information. A manufacturer of a new drug may file an extraordinary use new drug submission for the new drug if, under paragraph C.08.002.01(1): [2] (a) the new drug is intended for
This greatly expanded and improved version of the database included 1344 approved small molecule drugs and 123 biotech drugs as well as 3037 unique drug targets. Version 2.0 also included, for the first time, withdrawn drugs and illicit drugs , extensive food-drug and drug-drug interactions as well as ADMET (absorption, distribution, metabolism ...
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Only about 100 people in Canada have the disease, but at list prices Procysbi costs C$325,000 ($243,336.33) per year, according to Canadian regulators. Recordati to seek Canadian approval for ...
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 ...