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Vaccine PolicyProject Bioshield In his 2003 State of the Union Address, President Bush announced Project BioShield -- a comprehensive effort to develop and make available modern, effective drugs and vaccines to protect against attack by biological and chemical weapons or other dangerous pathogens. Project BioShield will:
Transcript of President Bush's remarks at NIH, 2/3/03 Two Animal Rule The FDA Animal Efficacy Rule (finalized May 2002) applies to development/testing of drugs/ biologicals to reduce or prevent serious/life-threatening conditions caused by exposure to lethal /permanently disabling toxic agent (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical. FDA can rely on evidence from animal studies to provide substantial evidence of product effectiveness when:
For more guidance on the two animal rule see the CBER/FDA Biodefense page HIPPA The U.S. Department of Health and Human Services (“HHS”) issued the Privacy Rule to implement the requirement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). iThe Privacy Rule standards address the use and disclosure of individuals’ health information—called “protected health information” by organizations subject to the Privacy Rule — called “covered entities,” as well as standards for individuals' privacy rights to understand and control how their health information is used. http://www.hhs.gov/ocr/hipaa/privacy.html |
Last revised: January 2, 2004