Department of Health and Human Services February 8, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S8 Immunotoxicity Studies for Human Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes a weight-of-evidence approach to determining whether additional immunotoxicity testing for nonbiological pharmaceuticals is appropriate when the findings from standard toxicity studies indicate signs of immunotoxicity. The draft guidance is intended to provide recommendations on nonclinical testing to identify compounds that have the potential to be immunosuppressive and guidance on a weight-of-evidence decision making approach for immunotoxicity testing.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Lactation StudiesStudy Design, Data Analysis, and Recommendations for Labeling.'' This guidance discusses agency recommendations on how and when to conduct clinical lactation studies and how to assess the influence of drugs or biologic products on lactation. The goals of this guidance are to provide the basic framework for designing, conducting, and analyzing clinical lactation studies and to stimulate further study and research to assist in rational therapeutics for lactating patients.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.