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HIV/AIDS
Milestones
1981
AIDS was first
reported.
1982
FDA received
first IND submission for treatment of AIDS.
1984
AIDS identified
as being caused by a human retrovirus, Human Immunodeficiency Virus
(HIV).
1985
FDA approved
first enzyme linked immunosorbant assay (ELISA) test kit to screen
for antibodies to HIV.
1987
On March 19,
FDA approved AZT – the first drug approved for the treatment
of AIDS.
1988
FDA implemented
new regulations designed to make promising therapies available
sooner
for patients with life-threatening and severely-debilitating diseases.
1989
FDA licensed
the
first diagnostic kit to detect the presence of HIV-1 by directly
detecting the proteins, or antigens, of the virus.
1990
On December
12,
FDA published a final rule defining acceptable quality levels
for
medical gloves and establishing the sampling plans and test methods
that FDA will use to determine whether gloves are adulterated.
On August 15,
1990, Congress passes the Ryan White Comprehensive AIDS Resources
Emergency (CARE) Act. This federal legislation addresses the
unmet health needs of persons living with HIV disease by funding
primary health care and support services. The CARE Act was named
after Ryan White, an Indiana teenager whose courageous struggle
with HIV/AIDS and against AIDS-related discrimination helped
educate the nation.
1991
The first combination
test to detect HIV-1 and HIV-2 antibodies was licensed by FDA to
Genetic Systems.
1992
On May 27, FDA
licensed SUDS HIV-1, a ten minute diagnostic test kit which can
be used by health professionals to detect the presence of HIV-1.
1993
On December 14,
FDA published an interim rule establishing a requirement for certain
infectious disease testing, donor screening, and record keeping
to help prevent the transmission of HIV and hepatitis B and C through
human tissue used in transplantation.
1994
On February
4,
U.S. Secretary of Health and Human Services Donna Shalala announced
the eighteen members of the National
Task Force on AIDS Drug Development, which includes experts in
AIDS
drug development issues from academia, industry, medicine, the
HIV/AIDS-affected
communities, and government.
1995
On September
8, FDA published in the Federal Register a proposed rule to amend
its regulations pertaining to investigational new drug applications
(INDs) and new drug applications (NDAs). The proposed rule is responsive
to one
to the recommendations made by the National Task Force on AIDS
Drug
Development. The proposed rule would clearly define in the NDA
format
and content requirements the need to present effectiveness and
safety
data for important demographic subgroups, specifically gender,
age,
and racial subgroups.
1996
On May 14, FDA
approved the first HIV test system that can be used at home and
can be purchased over-the-counter (OTC).
1997
On June 11, FDA
issued a Public Health Advisory regarding reports of diabetes and
hyperglycemia in patients receiving protease inhibitors for the
treatment of HIV-1.
1998
On February 27,
FDA cosponsored a 2 hour Satellite Broadcast from its Television
Studio discussing the guidelines for the use of Antiretroviral Agents
in HIV-Infected adults and Adolescents.
1999
Glass Capillary
Tubes: Joint Safety Advisory about Potential Risks, February 1999.
This document discusses the potential risk of injury and/or infection
from bloodborne pathogens, including HIV, Hepatitis B and Hepatitis
C viruses, due to the accidental breakage of glass capillary tubes,
and to recommend certain steps that can minimize the risk.
2000
President Clinton signs an executive order to help developing nations manufacture or import generic versions of patented antiretrovirals.
2001
The U.N. General Assembly holds its first special session on AIDS.
2002
The U.N.-backed Global Fund to Fight AIDS, Tuberculosis, and Malaria is created.
2003
The FDA approves Fuzeon, the first HIV entry inhibitor.
2004
A formulation of Videx is the first generic anti-HIV medication approved for U.S. sale.
2005
AZT’s patent expires, and four generic versions are approved for the U.S. market.
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