Dr Thomas commented regarding the Kryobulin licence application that despite precautions being taken, "the risk of transmission of serum hepatitis can only be diminished and not completely eliminated. Read more about Dr Thomas commented regarding the Kryobulin licence application that despite precautions being taken, "the risk of transmission of serum hepatitis can only be diminished and not completely eliminated.
The CSM accepted the recommendation from its Sub-Committee, and advised the grant of a product licence for Hemofil. Read more about The CSM accepted the recommendation from its Sub-Committee, and advised the grant of a product licence for Hemofil.
At a CSM(B) meeting, the Sub-Committee was informed that the manufacturer of Kryobulin PL/0215/0003 had not been visited recently, but the licensing authority intended to ask the Austrian authorities to carry out an inspection. Read more about At a CSM(B) meeting, the Sub-Committee was informed that the manufacturer of Kryobulin PL/0215/0003 had not been visited recently, but the licensing authority intended to ask the Austrian authorities to carry out an inspection.
Dr Thomas Cleghorn noted that plasma to manufacture initial supplies of Hemofil for the UK had not been individually RIA tested and had come from Puerto Rico, where they Hyland a blood bank. Read more about Dr Thomas Cleghorn noted that plasma to manufacture initial supplies of Hemofil for the UK had not been individually RIA tested and had come from Puerto Rico, where they Hyland a blood bank.
The Penrose Inquiry Report concluded that, in relation to blood products, "subjecting UK products to a need for approval to the FDA before introducing them for use in Scotland would not have been a rational exercise of judgement by any UK or Scottish government agency". Read more about The Penrose Inquiry Report concluded that, in relation to blood products, "subjecting UK products to a need for approval to the FDA before introducing them for use in Scotland would not have been a rational exercise of judgement by any UK or Scottish government agency".
A report on HIV and blood supply was critical of the FDA in the way it had managed regulation of blood and blood products in the early 1980s, and for having relied too heavily on the pharmaceutical industry. Read more about A report on HIV and blood supply was critical of the FDA in the way it had managed regulation of blood and blood products in the early 1980s, and for having relied too heavily on the pharmaceutical industry.
A two-year study on HIV and blood supply was conducted in the US by a Committee, established by the Institute of Medicine. Read more about A two-year study on HIV and blood supply was conducted in the US by a Committee, established by the Institute of Medicine.
Dr Michael Rodell (vice-president of the Armour Pharmaceutical Company) estimated that as few as four infected persons could contaminate the entire world supply of Factor 8 concentrate (his analysis was confined to concentrates made from US plasma). Read more about Dr Michael Rodell (vice-president of the Armour Pharmaceutical Company) estimated that as few as four infected persons could contaminate the entire world supply of Factor 8 concentrate (his analysis was confined to concentrates made from US plasma).
In the Netherlands patients could continue after the start of 1983 to receive commercial concentrates provided there was written evidence of their consent. Read more about In the Netherlands patients could continue after the start of 1983 to receive commercial concentrates provided there was written evidence of their consent.