October 18, 2022 – Federal Register Recent Federal Regulation Documents
Results 101 - 103 of 103
Certain Steel Nails From Taiwan: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments; 2020-2021
The U.S. Department of Commerce (Commerce) determines that certain steel nails from Taiwan were sold in the United States at less than normal value during the period of review (POR), July 1, 2020, through June 30, 2021. Commerce also determines that certain companies under review made no shipments of certain steel nails from Taiwan during the POR.
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.'' This guidance is intended to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). This guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for the development of drugs and biological products to support an indication of treatment of AML, including indications limited to an individual phase of treatment (for example, maintenance, transplantation preparative regimen, etc.). The guidance addresses the topics of general drug development, efficacy endpoints, and exploratory and confirmatory trial considerations for AML drug development. In addition, the guidance addresses investigational new drug applications, new drug applications, and biologics licensing applications for AML drugs. This guidance finalizes the draft guidance of the same title ``Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment'' issued August 2020.
Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.'' This guidance is intended for sponsors of cancer immunotherapeutic drugs that modulate the endogenous immune system and may break immunologic tolerance to normal organs and tissues; it provides recommendations regarding the data that should be collected and evaluated to assess whether adverse events are immune-mediated adverse reactions (imARs) and the data on imARs that should be included in a new drug application (NDA) or biologics license application (BLA) for a cancer immunotherapeutic drug.
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