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  1. HIV (Human Immunodeficiency Virus)

HIV Treatment

Treatment/Therapeutic Products

Among the regulatory activities related to regulation of therapeutic products, FDA:

  • Works with sponsors (developers) of new products to assure that clinical trials are well designed, scientifically sound, ethically conducted, and appropriately analyzed.

  • Works with the pharmaceutical industry and other researchers in the development of useful immune-based therapies, which may contribute to the body's own defense against HIV, and improve clinical outcome over drug therapy alone.

  • Offers technical assistance to researchers and manufacturers of medical treatments.

  • Reviews the data collected from clinical trials to establish evidence of safety and effectiveness.

  • Collects and evaluates information on adverse events associated with marketed drug products.

  • Disseminates timely product information to the medical community and the general public when safety issues arise related to therapies.

  • Works with the pharmaceutical industry and patients to provide information and a regulatory framework within which to allow access to promising investigational (unapproved) products when no practical, approved alternatives are available. Tens of thousands of patients have accessed promising, unapproved therapies through expanded access programs.
    More Information: See Understanding Expanded Access/Compassionate Use

More Information on medical products used to treat HIV/AIDS: