Guideto Further Reading

Baber N 1994 International conference on harmonization of technical requirements for registration of pharmaceuticals. British Journal of Clinical Pharmacology 37:401-404 Brass E P 2001 Changing the status of drugs from prescription to over-the-counter availability. New England Journal of Medicine 345: 810-816 Collier J 1999 Paediatric prescribing: using unlicenced drugs and medicines outside their licensed indications. British Journal of Clinical Pharmacology 48: 5-8 Conroy S et al 2000 Survey of unlicenced and off label drug use in paediatric wards in European countries. British Medical Journal 320: 79-82 DiMasi J A, Seibring M A, Lasagna L1994 New drug development in the United States from 1963 to 1992. Clinical Pharmacology and Therapeutics 55: 609-622

Gale EAM, Clark A 2000 A drug on the market?

Lancet 355: 61-63 Medicines Control Agency 1994 Guidelines for company-sponsored Safety Assessment of

Marketed Medicines (SAMM Guidelines). British Journal of Clinical Pharmacology 38: 95 Reichert J M 2000 New biopharmaceuticals in the USA: trends in development and marketing approvals 1995-1999. Trends in Biotechnology 18: 364-369

Richard B W et al 1987 Drug regulation in the United States and the United Kingdom: the Depo-Provera story. Annals of Internal Medicine 106: 886-891; (An analysis of how drug regulators in the USA and the UK came to opposite conclusions on the same data.)

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