In a memorandum from R E Tringham to Mr Lillywhite, Tringham made a comment in relation to the cost for supplying Factor V8 to Haemophilia Centres. He stated that he understands the Supply Division have received a "very favourable" tender from the company for the supply of Factor 8 to haemophilia centres, but of course, action on this depends upon the granting of a product license". Read more about In a memorandum from R E Tringham to Mr Lillywhite, Tringham made a comment in relation to the cost for supplying Factor V8 to Haemophilia Centres. He stated that he understands the Supply Division have received a "very favourable" tender from the company for the supply of Factor 8 to haemophilia centres, but of course, action on this depends upon the granting of a product license".
A report produced by Dr Andrews for the CSM (B) noted there was a hepatitis risk associated with Factorate. Read more about A report produced by Dr Andrews for the CSM (B) noted there was a hepatitis risk associated with Factorate.
An application was made by Armour Pharmaceuticals for the importation and distribution of Factorate. Read more about An application was made by Armour Pharmaceuticals for the importation and distribution of Factorate.
NIBSC offered to explain the quality control difficulties to a representative of Bayer. Read more about NIBSC offered to explain the quality control difficulties to a representative of Bayer.
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. Read more about 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.
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" Read more about 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"
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. Read more about 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.
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. Read more about 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.
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". Read more about 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".
The license for Koate contained no condition requiring the provision of ongoing data about donor rejections by center. Read more about The license for Koate contained no condition requiring the provision of ongoing data about donor rejections by center.