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FDA Regulation of Follow-On Biologics

Description: This report provides information about the FDA Regulation of Follow-On Biologics. A follow-on biologic is similar to the innovator product name by the pharmaceutical or biotechnology industry.
Date: August 6, 2007
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

FDA Regulation of Follow-On Biologics

Description: This report provides information about the FDA Regulation of Follow-On Biologics. A follow-on biologic is similar to the innovator product name by the pharmaceutical or C industry.
Date: April 7, 2008
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

FDA Regulation of Medical Devices

Description: This report provides a description of FDA's medical device review process divided into two parts: pre market requirements and post market requirements. Appendix A provides a brief history of laws governing medical device regulation and Appendix B provides a table of acronyms used in the report.
Date: June 25, 2012
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

The FDA Medical Device User Fee Program

Description: This report describes current law regarding medical device user fees, the impact of MDUFA on FDA review time of various medical device program budget, the MUDFA III proposal (legislative language and performance goals agreement), and issues that Congress is likely to take up as it works on the reauthorization of the medical device user fee program.
Date: April 24, 2012
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

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
open access

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
open access

Human Cloning

Description: This report provides information about the Human Cloning where a human embryo produced via cloning involves the process called somatic cell nuclear transfer. The nuclear of the egg is removed and replaced with a mature body cell.
Date: December 19, 2001
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

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 debat… more
Date: February 23, 2001
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

Human Cloning

Description: This report provides information about the Human Cloning where a human embryo produced via cloning involves the process called somatic cell nuclear transfer. The nuclear of the egg is removed and replaced with a mature body cell.
Date: March 10, 2003
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

Human Cloning

Description: This report provides information about the Human Cloning where a human embryo produced via cloning involves the process called somatic cell nuclear transfer. The nuclear of the egg is removed and replaced with a mature body cell.
Date: February 25, 2002
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

Human Cloning

Description: This report provides information about the Human Cloning where a human embryo produced via cloning involves the process called somatic cell nuclear transfer. The nuclear of the egg is removed and replaced with a mature body cell.
Date: May 2, 2002
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

Human Cloning

Description: This report provides information about the Human Cloning where a human embryo produced via cloning involves the process called somatic cell nuclear transfer. The nuclear of the egg is removed and replaced with a mature body cell.
Date: July 26, 2002
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

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
open access

Biotechnology: Commercialization of Academic Research

Description: This report provides an overview of the commercialization of academic research h in the field of biotechnology. It offers a brief definition, background and policy analysis, as well as legislation and hearings regarding the topic.
Date: October 26, 1981
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
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