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Biologics, Blood & Vaccines


Biologics, Blood & Most Popular
Vaccines 1 What’s New from CBER
Blood & Blood 2 Product Deviations
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Biologics, Blood & Vaccines


Biologics, Blood & Biologics, Blood & Vaccines > Blood & Blood Products
Vaccines
Blood & Blood
Products
Donating Blood Recalls & Approvals
FDA uses many methods to ensure a safe supply of blood and blood products:
Donating Blood Email Page
o Up-front screening. Donors are asked specific questions about risk factors
Level Five Link that could indicate infection, eliminating about 90 percent of unsuitable Print Page
donors. Bookmark and share
Level Five Link o Listings. Blood establishments must maintain lists of unsuitable donors.
o Testing. Donations are tested for seven different infectious agents. Get email updates
Level Five Link o Increased oversight. FDA inspects all blood establishments at least every
two years. “Problem” establishments are inspected more often. Subscribe to RSS
o High standards. Blood establishments must meet standards comparable
Level Five Link to those of pharmaceutical manufacturers.
o Better coordination. The Blood Action Plan (begun in 1997 and
continually revised) helps FDA coordinate its actions with other Public
Health Service (PHS) agencies.

As biological products, blood and blood products may always carry some risk of
transmitting infectious disease. FDA aims for the lowest risk possible that
allows adequate supply.

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Consumer Update – Have You Given Blood Lately?
More about blood safety and how to donate.

Keeping Blood Transfusions Safe - FDA’s Multi-


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layered Protections for Donated Blood
More about blood safety and how to donate. This information
Resources for You sheet is very similar to the consumer update, but older.

Consumers & Healthcare Blood Action Plan


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Providers Details on how FDA and other agencies regulate the blook
supply.
Industry

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Biologics, Blood & Vaccines


Biologics, Blood & Biologics, Blood & Vaccines > Blood & Blood Products 1 I think this list and the list below could be consolidated. The items are very
Vaccines similar. I don’t know enough to do it correctly, but someone else would and
could.
Blood & Blood Regulation of the Blood Supply
Products Recalls & Approvals
The FDA is responsible for ensuring the safety of our nation's blood supply.
Within FDA, the Center for Biologics Evaluation and Research (CBER): The first sentence of this paragraph duplicates the sentence on the “Donating
Regulation of the Email Page 2 Blood” page. It would be nice to keep the two in sync. Theoretically, the CMS
o Regulates collection of blood and blood components. These items may be
Blood Supply transfused or used to manufacture products such as clotting factors. would do this for you.
Print Page
o Establishes and enforces quality standards. 1
Blood Guidances o Regulates related products, such as cell separation devices, blood Bookmark and share
collection containers and HIV screening tests.
Review Checklist o Inspects blood establishments.
Get email updates These cross-link to the page where all the presentations are consolidated
3
o Monitors reports of errors, accidents and adverse clinical events. Subscribe to RSS (http://www.fda.gov/cber/summaries.htm#orbp).
Proposed & Final Rules
CBER works closely with other agencies of the Public Health Service (PHS) to:
o Identify and respond to potential threats
o Develop safety and technical standards
o Monitor blood supplies
o Help industry promote an adequate supply of blood and blood products.

As biological products, blood and blood products may always carry some risk of 2
transmitting infectious disease. But the blood supply is safer than it has ever
been.

Overview of the Regulation of Biological Products


3
Regulation of blood components and tissues, 3/12/2008.

o Surveillance and Enforcement (PDF - 88 KB) - Armando Zamora

o The Regulation of Biological Products (PDF - 788 KB) - Judy Ciaraldi, Linda
S. Mattingly, Armando Zamora, Sharon O'Callaghan, Laura St. Martin, MD
Resources for You
o FDA Field Inspections (PDF - 60 KB) - Linda S. Mattingly
Consumers & Healthcare o FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based
Providers Products (HCT/Ps) (PDF – 173 KB) – Laura M. St. Martin, M.D., M.P.H.

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