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The FDA Medical Device User Fee Program: MDUFA IV Reauthorization

Description: This report describes current law regarding medical device user fees, the impact of Medical Device User Fee and Modernization Act (MDUFMA) on Federal Drug Administration (FDA) review time of various medical device applications, and the agency's medical device program budget.
Date: June 6, 2016
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

Disease Funding and NIH Priority Setting

Description: Research at the National Institutes of Health (NIH) has strong political support, but a heated debate rages over the allocation of NIH funds among various diseases. NIH contends that decisions are made based on scientific opportunity while critics of the NIH process charge that spending often follows current politics and political correctness.
Date: September 10, 1998
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

AIDS Funding for Federal Government Programs: FY1981-FY1999

Description: This report provides a synopsis of the budget activity related to AIDS from the discovery of the disease in 1981 through FY1999. Funding for AIDS research, prevention and treatment programs within the Department of Health and Human Services (HHS) discretionary budget has increased from $200,000 in FY1981 to an estimated $3.85 billion in FY1999.
Date: March 31, 1998
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

Abortion: Termination of Early Pregnancy with RU-486 (Mifepristone)

Description: On September 28, 2000, the Food and Drug Administration (FDA) approved the drug mifepristone, also known as RU-486, for the termination of early pregnancy. Because RU-486 is an abortion agent, the process of moving it out of the lab and into mainstream medicine has been fraught with controversy. Since its discovery, the pro-life movement has been adamantly against the use of this drug for abortion. This report discusses the procedure of obtaining and using the drug, as well as the ongoing debate regarding its usage and related legislation.
Date: February 23, 2001
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

FDA Regulation of Follow-On Biologics

Description: This report provides a brief introduction to the relevant law regarding follow-on biologics, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a description of the proposed legislation.
Date: February 24, 2009
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

Stem Cell Research

Description: This report provides background on the research and potential applications of research that uses embryonic and adult stem cells. It also provides information about the current federal and state regulatory landscape, related Congressional and international actions, and relevant ethical concerns.
Date: August 13, 2004
Creator: Johnson, Judith A. & Williams, Erin
Partner: UNT Libraries Government Documents Department

Stem Cell Research

Description: This report provides background on the research and potential applications of research that uses embryonic and adult stem cells. It also provides information about the current federal and state regulatory landscape, related Congressional and international actions, and relevant ethical concerns.
Date: December 13, 2004
Creator: Johnson, Judith A. & Williams, Erin
Partner: UNT Libraries Government Documents Department