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A fast track application is automatically considered for both of these designations. Rolling review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review ...
The PDUFA date thus serves as a 'best estimate' of when a decision on a New Drug Application or a Biologics License Application would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL). The PDUFA date may be extended by the Food and Drug Administration in certain circumstances. [6]
Multinational investment management company based in Toronto. 232 Power Corporation of Canada: $55,488 33,700 Diversified international management company primarily focused on the financials sector and including holdings in telecommunications and media. Subsidiaries include Power Financial, Gesca and Great-West Lifeco. 277 Manulife Financial ...
Pages in category "Pharmaceutical companies of Canada" The following 24 pages are in this category, out of 24 total. This list may not reflect recent changes .
List of defunct Canadian companies; E. List of Canadian electric utilities; F. Foreign ownership of companies of Canada; I. List of insurance companies in Canada;
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
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). [3] [6]
The Food and Drugs Act (French: Loi sur les aliments et drogues) is an act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of food, drugs, contraceptive devices and cosmetics (including personal cleaning products such as soap and toothpaste).