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Oversight of Gulf Coast Hurricane Recovery: Semiannual Report to Congress, October 1, 2006 - March 31, 2007
"This is the third in a series of semiannual reports on Gulf Coast hurricane recovery oversight. The report details the efforts that are a part of the oversight of the activities and expenditures directly linked to the recovery from the devastating 2005 hurricane season. Inspector General oversight continues with the ultimate goal of identifying fraud, waste, and abuse, and ensuring that the assets and resources employed in the recovery are used efficiently and effectively. The efforts of the Inspector General community continue to benefit the Federal government's hurricane relief activities."
Center for Biologics Evaluation and Research (U.S.)
2008-08
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Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines
"This document is intended to provide to you, sponsors of seasonal inactivated influenza vaccines, guidance on clinical development approaches to support a Biologics License Application (BLA). The approaches in this guidance apply to both nonadjuvanted and adjuvanted hemagglutinin-based seasonal vaccines, including 'split virus,' subunit, and whole virus inactivated vaccines propagated in embryonated chicken eggs or cell-culture, and to recombinant hemagglutinin-based protein vaccines, and DNA vaccines that express hemagglutinin. This document does not address live attenuated influenza vaccines or influenza vaccines that do not rely on immunity to a hemagglutinin component. We, FDA, recognize that in the past there have been monovalent and bivalent inactivated influenza vaccines for seasonal influenza. To provide flexibility for evolving public health needs, including the development of vaccines with either more than three or fewer than three antigens, this guidance uses the term 'seasonal inactivated influenza vaccine.' This document does not address the nonclinical or early clinical development of investigational vaccines. Successful evaluations of nonclinical and early clinical development are important steps before proceeding with additional clinical development (Ref 1). This document also does not address the chemistry, manufacturing, control, or inspection of the manufacturing facility needed for licensure. These aspects of the license application are addressed in the guidance document entitled, 'Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related Product.' Applicants may contact the Center for Biologics Evaluation and Research (CBER) for additional information about these aspects of vaccine development."
Center for Biologics Evaluation and Research (U.S.)
2007-05
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Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
"This document is intended to provide to you, sponsors of pandemic influenza vaccines, guidance on clinical development approaches to facilitate and expedite the licensure of influenza vaccines where the intended indication is for active immunization in persons at high risk of exposure to, or during a pandemic caused by, pandemic influenza viruses. We, FDA, also discuss pursuing licensure of an influenza vaccine for indication and usage during the prepandemic stage in Section III.D.5. -- Investigating Schedules for Administration for Use Prior to a Pandemic. The approaches in this guidance apply to both nonadjuvanted and adjuvanted hemagglutinin-based pandemic vaccines, including 'split virus,' subunit, and whole virus inactivated vaccines propagated in embryonated chicken eggs or cell-culture, and to recombinant hemagglutinin-based protein vaccines, and DNA vaccines that express hemagglutinin. We also address live attenuated influenza vaccines. This document does not address influenza vaccines that do not rely on immunity to a hemagglutinin component. This document does not address the nonclinical development of investigational vaccines. Successful nonclinical evaluation is an important step before proceeding with clinical development (Ref. 1). This document also does not address the chemistry, manufacturing, control, or inspection of the manufacturing facility needed for licensure. These aspects of the license application are addressed in the guidance document entitled, 'Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related Product.' 1 Applicants may contact the Center for Biologics Evaluation and Research (CBER) for additional information about these aspects of vaccine development."
Center for Biologics Evaluation and Research (U.S.)
2007-05
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Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
This guidance document represents the agency's current thinking on the topic of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products. CJD is a rare but invariably fatal degenerative disease of the central nervous system, associated with a poorly understood transmissible agent. This document offers continued recommendations for halting the proliferation of CJD and nvCJD in America. The authors write, "This guidance document contains comprehensive revised recommendations based upon advisory committee discussions, public comments to the docket and at advisory committee meetings, and internal Public Health Service and FDA deliberations. We have developed recommendations for donor deferral, product retrieval, and quarantine and disposition based upon consideration of risk in the donor and product, and the effect that withdrawals and deferrals might have on the supply of life-and health-sustaining blood, blood components and plasma derivatives. In particular, donors with vCJD are distinguished from those with CJD or CJD risk factors, because of very limited historical and epidemiological experience with vCJD, known pathological differences between CJD and vCJD, and uncertainty about the potential for vCJD transmission by blood transfusion. The new recommendations reflect an attempt to minimize the possible risk of vCJD transmission from blood and blood products consistent with maintaining their availability." The authors further submit that, "in anticipation of the new geographic deferral recommendation, we strongly encourage proactive planning to ensure blood supply adequacy before, during, and after implementation."
United States. Food and Drug Administration; Center for Biologics Evaluation and Research (U.S.)
2002-01
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Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry
From the Introduction: "This revised guidance document provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA's revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. We (FDA) are also recommending that you make corresponding revisions to your donor educational materials, donor history questionnaires and accompanying materials, along with revisions to your donor requalification and product management procedures. This guidance also incorporates certain other recommendations related to donor educational materials and supersedes the December 2015 guidance of the same title (Notice of Availability, 80 FR 79913 (December 17, 2015)). The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma."
United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Biologics Evaluation and Research (U.S.)
2020-04
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Investigational COVID-19 Convalescent Plasma: Guidance for Industry
From the Introduction: "The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States (U.S.) from threats including emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma."
United States. Food and Drug Administration; United States. Department of Health and Human Services; Center for Biologics Evaluation and Research (U.S.)
2020-04-13
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Investigational COVID-19 Convalescent Plasma: Guidance for Industry [September 2, 2020]
From the Introduction: "FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. On August 23, 2020, FDA issued an Emergency Use Authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application (IND). For the purposes of this guidance, the term 'COVID-19 convalescent plasma' refers to the convalescent plasma authorized under the EUA, while the term 'investigational convalescent plasma' refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND. FDA is issuing this guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the public health emergency. The guidance also provides recommendations to blood establishments on collection. We also describe FDA's interim compliance and enforcement policy regarding the IND requirements for the use of investigational convalescent plasma. This document supersedes the guidance of the same title issued in April 2020 and updated in May 2020."
United States. Food and Drug Administration; United States. Department of Health and Human Services; Center for Biologics Evaluation and Research (U.S.)
2020-09-02
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Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing: Guidance for Industry
From the Introduction: "FDA [U.S. Food and Drug Administration] plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding: [1] Manufacturing controls to prevent contamination of drugs; [2] Risk assessment of SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] as it relates to drug safety or quality; [3] Continuity of manufacturing operations."
United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Drug Evaluation and Research (U.S.) . . .
2020-06
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