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An application for variation of product licence for Kryobulin was submitted.

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An application was made to vary the product licence for Kryobulin, in order to allow for the use of radioimmunoassay (RIA) testing for Hepatitis B antigen.

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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.

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The report stated donors met the criteria of the regulations and each was tested for syphilis.

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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.

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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.

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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.

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The licence application for Koate (made by Cutter) was submitted.

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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."

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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.

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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.

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The UK product licence for Koate stated that the presence of hepatitis should be assumed.

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The license for Koate contained no condition requiring the provision of ongoing data about donor rejections by center.

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Bayer informed Dr Andrews regarding Koate, that Cutter did not collect information about the rejection of donors. Nonetheless, they gave an assurance that "the collection of plasma is carried out according to the US Code of Federal Regulations".

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Cutter confirmed regarding the Koate licence application that the pool size was 2500 litres of plasma, but the DHSS were told that Cutter did not collect information about the rejection of donors.

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Bayer UK stated that Cutter did not collect information on the reasons for, and the rate of, rejection of donors or donations, centre by centre.

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Dr John Holgate stated regarding the licencing process that, "It is one thing to have regulations and another to learn of the enthusiasm with which they are carried through"

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NIBSC stated they would not agree to the licensing of a product unless there were batch release procedures due to bad experiences in the past where deficiencies in proper formulation of information on protocols, and unacceptable assay biometry and methods were seen.

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NIBSC offered to explain the quality control difficulties to a representative of Bayer.

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An application was made by Armour Pharmaceuticals for the importation and distribution of Factorate.

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