1981 AIDS was first reported.

1981

AIDS was first reported.

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1982

FDA received first IND submission for treatment of AIDS.

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1984

AIDS identified as being caused by a human retrovirus, Human Immunodeficiency Virus (HIV).

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1985

FDA approved first enzyme linked immunosorbant assay (ELISA) test kit to screen for antibodies to HIV.

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1987

On March 19, FDA approved AZT - the first drug approved for the treatment of AIDS.

On April 29, FDA approved the first Western blot blood test kit - a more specific test.

On August 18, FDA sanctioned the first human testing of a candidate vaccine against HIV.

FDA Published regulations which require screening all blood and plasma collected in the U.S. for HIV antibodies.

FDA completed studies demonstrating the safety of immune globulin products. The efficacy of viral inactivation and partitioning during manufacturing procedures was confirmed.

FDA revised its strategy for the regulation of condoms by strengthening its inspection of condom manufacturers and repackers, strengthening its sampling and testing of domestic and imported condoms in commercial distribution, and providing guidance on labeling of condoms for the prevention of AIDS.