Department of Health and Human Services September 5, 2008 – Federal Register Recent Federal Regulation Documents
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Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product- specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Gamma-hydroxybutyric acid; Ketamine; Dextromethorphan; N-benzylpiperazine; 1-(3-trifluoromethylphenyl)piperazine; 1-(3-chlorophenyl)piperazine; 1-(4-Methoxyphenyl)piperazine; 1-(3,4-methylenedioxybenzyl)piperazine; Gamma-butyrolactone; 1,4-Butanediol
The Food and Drug Administration (FDA) is requesting comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drug substances. These comments will be considered in preparing the United States' response to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (CSA).
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