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Approved therapies, treatment guidelines.
"Fast track" drug programs, pediatric patients, studying
therapeutics in women.
IND Application Process: What you need to know about requirements
and guidances necessary for drug development and marketing
approval.
Getting started with the Pre-IND process in development of
HIV/AIDS therapies.
Task forces combating scams relating to HIV/AIDS, cancer, dietary
supplements, and other treatments.
Such as condoms, gloves and other medical devices.
Home test kits (legitimate and fraudulent) and clinical setting
tests.
Men who have had sex with another man (MSM): Donor deferral
based on sexual risk behaviors
Significant events 1981 - present
A program developed to bring the patient voice to the table
at FDA advisory committee meetings, and assure patient community
input into regulatory issues and drug approval. |
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Late breaking information, as well as an archival record of updates on safety and regulatory issues related to HIV/AIDS, dating from 2002 to present. Information includes
- product approvals
- significant labeling changes
- safety warnings
- notices of upcoming public meetings
- notices about proposed regulatory guidances
You can get updates on drug safety and regulatory issues
related to HIV/AIDS by joining the FDA HIV/AIDS List
Serve.
- Podcast at AIDS.gov
Richard Klein, FDA HIV/AIDS Program Director describes FDA's
role in HIV
Other Government Resources
AIDS.gov
An information gateway to guide users to federal domestic HIV/AIDS information
and resources, providing access to information on federal HIV/AIDS prevention,
testing, treatment, and research programs, policies, and resources.
AIDSInfo
Information about the current treatment regimens for
HIV infection and AIDS-related illnesses, including the prevention
of HIV transmission from occupational exposure and mother-to-child
transmission during pregnancy.
AIDSinfo is also a resource for current information on clinical
trials for AIDS patients and others infected with HIV.
Divisions
of HIV/AIDS Prevention (Centers for Disease Control and
Prevention) provides information about populations affected
by HIV/AIDS, and prevention.
National
Prevention Information Network (CDC)
the nation's largest collection of information
and resources on HIV/AIDS, STD and TB prevention.
Division
of AIDS (National Institutes of Health) provides information
about HIV/AIDS prevention, therapeutics, and vaccine research.
HIV/AIDS Bureau (Health Resources
and Services Administration) provides information about
the Ryan White Care Act (which fills gaps in health care
for people with HIV disease for those with low-incomes
and little or no insurance), grant opportunities, education,
and training.
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Contact the HIV/AIDS Program
Contact the Office of Special
Health Issues
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HIV and AIDS