The UK product licence for Koate stated that the presence of hepatitis should be assumed. Read more about The UK product licence for Koate stated that the presence of hepatitis should be assumed.
In early January 1976, CSM (B) recommended the grant of a licence which was subject to conditions. It particularly sought information regarding the pool size, and the reasons for and rate of donor rejection centre by centre. Read more about In early January 1976, CSM (B) recommended the grant of a licence which was subject to conditions. It particularly sought information regarding the pool size, and the reasons for and rate of donor rejection centre by centre.
Dr R D Andrews mentioned in his assessment report, regarding the Koate licence application, each donation was RIA tested for HBV antigen and that there had been no reports attributing hepatitis to Koate since the introduction in the US in February 1974. Read more about Dr R D Andrews mentioned in his assessment report, regarding the Koate licence application, each donation was RIA tested for HBV antigen and that there had been no reports attributing hepatitis to Koate since the introduction in the US in February 1974.
Dr R D Andrews noted in his assessment report, regarding the Koate licence application, that plasma for Koate (made by Cutter) was supplied from 54 different firms under various ownership, including US State prisons, and "suffers from being prepared from multi-centre donations which cannot be properly controlled by inspection." Read more about Dr R D Andrews noted in his assessment report, regarding the Koate licence application, that plasma for Koate (made by Cutter) was supplied from 54 different firms under various ownership, including US State prisons, and "suffers from being prepared from multi-centre donations which cannot be properly controlled by inspection."
The licence application for Koate (made by Cutter) was submitted. Read more about The licence application for Koate (made by Cutter) was submitted.
In a journal article, E K Blackburn stated that those who were in charge of patients with haemophilia no longer felt they can tolerate the undertreatment of their patients. Read more about In a journal article, E K Blackburn stated that those who were in charge of patients with haemophilia no longer felt they can tolerate the undertreatment of their patients.
In a letter to the Editor of the Lancet, Dr Biggs discussed the shortage of Factor 8 for the treatment of haemophilia patients and how this could be improved with proper financial investment. Read more about In a letter to the Editor of the Lancet, Dr Biggs discussed the shortage of Factor 8 for the treatment of haemophilia patients and how this could be improved with proper financial investment.
Dr Biggs stated in a letter to Dr Sheila Waiter that Commercial Human Factor 8 should be made available to doctors who treat patients with haemophilia as an interim measure until enough can be made by the NHS. Read more about Dr Biggs stated in a letter to Dr Sheila Waiter that Commercial Human Factor 8 should be made available to doctors who treat patients with haemophilia as an interim measure until enough can be made by the NHS.
The report stated donors met the criteria of the regulations and each was tested for syphilis. Read more about The report stated donors met the criteria of the regulations and each was tested for syphilis.
In the report regarding the product licence application of the Antihemophilic Factor, it was noted that the donors met the criteria of the regulations and each was tested for syphilis. The medical assessor also added that there had been no inspection of the manufacturing facilities. Read more about In the report regarding the product licence application of the Antihemophilic Factor, it was noted that the donors met the criteria of the regulations and each was tested for syphilis. The medical assessor also added that there had been no inspection of the manufacturing facilities.