Dr Kingdon recorded that:"All importation stopped following the FDA direction that source plasma and the centres producing source plasma be licensed; the FDA would not inspect offshore sites which meant that imported plasma would not be approved plasma and therefore could no longer be used in the manufacture of blood products. As a result, since approximately 1978, all plasma used for the production of concentrates in the United States has been obtained from donors in the United States." Read more about Dr Kingdon recorded that:"All importation stopped following the FDA direction that source plasma and the centres producing source plasma be licensed; the FDA would not inspect offshore sites which meant that imported plasma would not be approved plasma and therefore could no longer be used in the manufacture of blood products. As a result, since approximately 1978, all plasma used for the production of concentrates in the United States has been obtained from donors in the United States."
The size of pool used by Hyland/Travenol appears to have increased over time as, in his draft statement of 1990, Dr Kingdon referred to "start pool" sizes of up to 15,000 donations. He did not provide further details of when, how and why the pool size had changed. Read more about The size of pool used by Hyland/Travenol appears to have increased over time as, in his draft statement of 1990, Dr Kingdon referred to "start pool" sizes of up to 15,000 donations. He did not provide further details of when, how and why the pool size had changed.
According to Dr Kingdon, the United States plasma collection centres tended to be located near areas where there was likely to be a population willing to spend 2-3 hours donating plasma for a small payment (near universities, army bases and in the lower socio-economic sections of a city). Read more about According to Dr Kingdon, the United States plasma collection centres tended to be located near areas where there was likely to be a population willing to spend 2-3 hours donating plasma for a small payment (near universities, army bases and in the lower socio-economic sections of a city).
According to Dr Kingdon, the United Stated Federal Drug Administration's inspections of blood and plasma centres were important for changing practices in the plasma industry. Read more about According to Dr Kingdon, the United Stated Federal Drug Administration's inspections of blood and plasma centres were important for changing practices in the plasma industry.
According to Dr Kingdon, a manufactured product might had a shelf life of two years. Read more about According to Dr Kingdon, a manufactured product might had a shelf life of two years.
According to Dr Kingdon, it was unlikely that the industrial manufacturers in the US would have continued to use imported plasma in the manufacture of concentrates for any significant period as much of the imported plasma was infected with HBV. Read more about According to Dr Kingdon, it was unlikely that the industrial manufacturers in the US would have continued to use imported plasma in the manufacture of concentrates for any significant period as much of the imported plasma was infected with HBV.
According to Dr Kingdon, all plasma used for the production of concentrates in the United States had been obtained from donors in the United States. Read more about According to Dr Kingdon, all plasma used for the production of concentrates in the United States had been obtained from donors in the United States.
According to Dr Kingdon, the United States Federal Drug Administration (FDA) mandated source plasma as a licensed product. In order to obtain a licence for the production of source plasma every collection centre must be inspected annually by the FDA. Read more about According to Dr Kingdon, the United States Federal Drug Administration (FDA) mandated source plasma as a licensed product. In order to obtain a licence for the production of source plasma every collection centre must be inspected annually by the FDA.
Data sheets and product leaflets relating to Kryobulin did not mention AIDS, HTLV-3, LAV or HIV. Read more about Data sheets and product leaflets relating to Kryobulin did not mention AIDS, HTLV-3, LAV or HIV.
Companies could voluntarily submit product data sheets to a compendium produced annually by the Association of British Pharmaceutical Industry ("ABPI"). Read more about Companies could voluntarily submit product data sheets to a compendium produced annually by the Association of British Pharmaceutical Industry ("ABPI").