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Personal perspectives.
September 22, 2002... Harmonization of pharmaceutical regulation between CADREAC and the European Union *
"Omnium graduum dificillimus est primus" -- The first step is the most difficult (Roman saying)
By 1997, ten countries from Central and Eastern...
Vaccines and biomedicines.
September 22, 2002... Gene transfer medicinal products *
Gene therapy as currently known began in the United States of America in 1989 when cancer patients were treated with tumour-infiltrating lymphocytes transduced with a marker gene to track in vivo...
Safety issues.
September 22, 2002... Interactions with grapefruit juice
The serendipitous discovery in 1991 of the interaction of grapefruit juice with drugs occurred when grapefruit juice was used to mask the taste of ethanol in a study testing an interaction between the...
Regulatory and safety action.
September 22, 2002... Gene therapy retroviral vector trials "on hold"
United States of America -- The Food and Drug Administration (FDA) has placed on "clinical hold" all active gene therapy trials using retroviral vectors to insert genes into blood stem...
International Nonproprietary Names (INN).
September 22, 2002... The Programme on International Nonproprietary Names (INNs) was established by the World Health Organization in the 1950s. The main task of the Programme is to designate names for pharmaceutical substances to be used for medical purposes...