Health and Human Services Logo

  U.S. Department of Health and Human Services | National Institutes of Health

Biologics Regulation and ResearchThe People and Work of Buildings 29 & 29A

Versions Compared

Old Version 45

changes.mady.by.user Katie Watts

Saved on

compared with

New Version 46

changes.mady.by.user Katie Watts

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Dive
preface
classgrid-row grid-gap
Dive
classgrid-col-6

Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV) was licensed by FDA in 1990.  Since an immune-suppressed organ recipient may be unable to fight off the effects of the virus, this action would help to protect kidney transplant patients from the effects of cytomegalovirus that may have been transmitted through the organ of CMV-positive donors.

In July 1986 FDA licensed the first therapeutic monoclonal antibody, Muromonab CD-3, to treat acute rejection of transplanted kidneys.  The biologic bound to the T cell CD-3 antigen and rapidly dispatched the T lymphocytes.

Dive
classgrid-col-6

a chart showing Monoclonal Antibody Production

Span
classcaption

Monoclonal Antibody Production (from CBER’s publication, From a Rich History to a Challenging Future (2002). 

Span
classcredit

FDA History Office


In May 2005, new regulations took effect requiring human tissue firms to properly screen and test donors among other aspects of operations.  These also provided for swift action to be taken by FDA in the interest of public health.  Applying these new regulations early in 2006, FDA issued to a Ft. Lee, New Jersey, human tissue recovery firm an order to immediately cease all manufacturing operations.  The agency monitored the recall of all their tissues to ensure completeness of the operation.  So egregious were the deficiencies in the firm’s manufacturing practices, donor screening, record keeping, and other operations that, according to a senior agency official, “allowing the firm to manufacture would present a danger to public health by increasing the risk of communicable disease transmission.”

...
Return to top