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Once a doctor decides a patient is a candidate for isotretinoin, [10] they counsel the patient to ensure they understand the drug and the potential side effects. Once the patient signs the necessary paperwork, their doctor will give them a patient ID number, ID card, and program educational materials.
The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, [43] and in 2004 by David Healy in evidence to the House of Commons Health Committee, [44] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.
Isotretinoin is a pharmaceutical derivative of retinoic acid (a metabolite of vitamin A). Its mechanism of action is believed to involve reduction in the amount of sebum produced by sebaceous glands on the skin's surface.
Usage of the database is free of charge and it has no promotional texts or advertising. [15] FASS has been developed by the Swedish Association of the Pharmaceutical Industry (LIF) in close cooperation with Sweden's pharmaceutical industry , with additional assistance from the Medical Products Agency , the Pharmaceutical Benefits Board and the ...
Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. [3]
The name isotretinoin is the same root tretinoin plus the prefix iso-. Regarding pronunciation, the following variants apply equally to both tretinoin and isotretinoin. Given that retinoic is pronounced / ˌ r ɛ t ɪ ˈ n oʊ ɪ k /, [43] [44] [42] [45] it is natural that / ˌ t r ɛ t ɪ ˈ n oʊ ɪ n / is a commonly heard pronunciation.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
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.