Download e-book for kindle: Regulation of Medical Products by John Griffin, John O'Grady

By John Griffin, John O'Grady

ISBN-10: 0585444021

ISBN-13: 9780585444024

ISBN-10: 0727917803

ISBN-13: 9780727917805

A concise yet accomplished textual content explaining the strategies eager about rules of gear with specific emphasis on ecu, united states and Australia.

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Example text

Major drugs withdrawn between 1971 and 1982 for safety reasons included polidexide (introduced 1974 and withdrawn 1975), oral formulation of practolol (1970 and 1976), alclofenac (1972 and 1979), tienilic acid (1979 and 1980), clomacron (1977 and 1982) and indoprofen (1982 and 1982). Practolol illustrated well not only the value of a spontaneous reporting system but also the depth to which the Committee would investigate a signal of a serious ADR. Practolol-induced eye damage first came to light as a result of a publication by an ophthalmologist.

In addition, the generic name and the NHS cost were also required to appear. Further regulations (SI 1978/41) were also introduced on 1 February 1978 in respect of advertising direct to the public. Part of this made it an offence to advertise any product for certain serious diseases. In 1977, agreement was also reached with the ABPI for voluntary control and monitoring of advertisements by the industry and the ABPI instituted a Code of Practice and a Committee to supervise its implementation. In 1975, the Medicines Division set up the Advertising Action Group to monitor advertising.

Her Majesty’s Stationery Office, London, 1972. Committee on Safety of Medicines. Report for the year ended 31 December 1971. Her Majesty’s Stationery Office, London, 1972. Committee on Safety of Medicines. Report for the year ended 31 December 1972. Her Majesty’s Stationery Office, London, 1973. The Medicines Commission. Annual Report for 1973 (together with annual reports of standing committees appointed under section 4 of the Medicines Act 1968). Her Majesty’s Stationery Office, London, 1974.

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Regulation of Medical Products by John Griffin, John O'Grady


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