Department of Health and Human Services December 8, 2022 – Federal Register Recent Federal Regulation Documents
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Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria.'' The guidance document provides blood establishments that collect blood and blood components with FDA's recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The recommendations contained in the guidance apply to the collection of Whole Blood and blood components, except Source Plasma. The guidance announced in this notice supersedes the guidance entitled ``Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry'' dated April 2020.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Availability of Final Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns
The Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR), located within the Department of Health and Human Services (HHS) announces the availability of the final Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns (2022 Guidelines). The 2022 Guidelines provide updates to the 2013 publication, Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from the CDC and the Council of State and Territorial Epidemiologists (CSTE). The updates provide state, tribal, local, and territorial health departments guidance for a revised and expanded approach to evaluating concerns about unusual patterns of cancer in communities, including those associated with local environmental concerns. The 2022 Guidelines finalize the draft guidelines issued on May 25, 2022.
Determination That NORFLEX (Orphenadrine Citrate) Injection, 30 Milligrams/Milliliter, and NORFLEX (Orphenadrine Citrate) Extended-Release Tablet, 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that NORFLEX (orphenadrine citrate) Injection, 30 milligrams (mg)/milliliter (mL), and NORFLEX (orphenadrine citrate) Extended- Release Tablet, 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Teva Branded Pharmaceutical Products R and D, Inc., et al.; Withdrawal of Approval of 35 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 35 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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