Bovine heparin position statement on the reintroduction

[flatfish]

Wednesday, January 28, 2015

BOVINE HEPARIN POSITION STATEMENT ON THE REINTRODUCTION and POTENTIAL BSE TSE PRION RISK FACTORS THEREFROM

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kind regards, terry

[flatfish]

SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION

Wednesday, June 4, 2014

FDA White Oak Campus

Building 31, Room 1503

10903 New Hampshire Avenue

Silver Spring, Maryland 20993

The meeting was convened at 8:32 a.m., Russ ALTMAN,

snip...

So it has been shown -- so how would you -- there is a risk, though. There is a theoretical risk of any herd or whatever having contamination. So how can you mitigate even that very small risk? It has been shown that the existing manufacturing processes could remove or inactive BSE agents if present. This is because they're an extremely robust extraction under very harsh conditions.SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION

The FDA has guidelines regarding TSEs that can be applied to heparin, and these generally were developed by CBER and include control of animal sources, which obviously is critical, selection of the type of tissue used, incorporation of risk-reduction steps into the production process. And, of course, this is typical for any animal source material or even human source material that we use in other people, and so that's what we'd like to talk about today.

UNIDENTIFIED SPEAKER: Janet, what's a TSE?

DR. WOODCOCK: Pardon me?

UNIDENTIFIED SPEAKER: What is a TSE?

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I friggen give up...tss

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snip...see full text ;



Sunday, February 08, 2015

FDA SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION BOVINE HEPARIN BSE CJD TSE PRION Wednesday, June 4, 2014

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