Department of Health and Human Services April 13, 2006 – Federal Register Recent Federal Regulation Documents
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International Conference on Harmonisation; Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S8 Immunotoxicity Studies for Human Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations on nonclinical testing approaches to identify compounds that have the potential to be immunotoxic and guidance on a weight-of-evidence decisionmaking approach for immunotoxicity testing. The guidance is intended to provide recommendations on nonclinical testing for immunotoxicity induced by human pharmaceuticals. The guidance applies to unintended immunosuppression and immunoenhancement, excluding allergenicity or drug-specific autoimmunity.
Stakeholder Meeting to Discuss the Possible Implementation of Two Review Performance Goals Referenced in the Medical Device User Fee and Modernization Act of 2002; Public Meeting
The Food and Drug Administration (FDA) is announcing the following public meeting: Stakeholder Meeting to Discuss the Possible Implementation of Two Review Performance Goals referenced in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). In a letter that accompanied the user fee legislation, the agency committed to a number of review performance goals. These goals include a commitment that 50 percent of the premarket approval applications received in fiscal year (FY) 2007 will have an FDA decision in 180 days and 80 percent of the premarket notifications will have an FDA decision in 90 days. The letter states that these goals are to be re-evaluated following the end of FY 2005 and FDA is to hold a public meeting to consult with its stakeholders and to determine whether the goals are appropriate for implementation in FY 2007.
Changes to the National Registry of Evidence-Based Programs and Practices (NREPP); Correction
The Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice regarding changes to the National Registry of Evidence-based Programs and Practices (NREPP) in the March 14, 2006 Federal Register. This document contained several comments from the American Psychological Association's Division 50 Committee on Evidence- based Practice that were incorrectly attributed to the full American Psychological Association.
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