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Biosimilars Action Plan: Balancing Innovation and Competition
"Congress has given the U.S. Food and Drug Administration (FDA), as part of the agency's mission to promote and protect the public health, responsibility for implementing laws intended to strike a balance between encouraging and rewarding innovation in drug development and facilitating robust and timely market competition. Maintaining this balance between innovation and access requires a mix of statutory and regulatory measures, such as creating incentives for innovation in the form of exclusivity periods; modernizing regulatory requirements to maintain efficient, predictable and science-based pathways for drug review with the aim of reducing the time, uncertainty, and cost of drug development; and supporting a competitive marketplace through the efficient approval of lower-cost generic and biosimilar alternatives."
United States. Food and Drug Administration
2018-07
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FDA Strategy for the Safety of Imported Food
"Today, the nation imports food from more than 200 countries or territories and approximately 125,000 exporting food facilities plus farms. To meet consumers' growing demands, globalization of the food supply and adaptations of the food industry have resulted in more complex supply chains, varying business models, and increased specialization. The Food and Drug Administration (FDA or 'agency') oversees the safety of most of the human and animal food ('food') consumed in the United States. An important aim of the agency's strategy for the safety of imported food is to assure Americans that food imported from abroad is held to the same food safety requirements as food produced domestically. In the past, FDA's imported food safety system focused on intercepting unsafe food at the border and preventing its entrance into the U.S. marketplace. As the volume of imports increased, along with a diversity of products and countries of origin (see Figures 2 and 3) the traditional regulatory oversight model was challenged. In 2019, between 14 and 15 million shipments of imported food are expected to enter the United States."
United States. Food and Drug Administration
2019-02
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Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health
"Medical devices play a crucial role in the treatment and diagnosis of illness and disease. They range from common medical supplies (bandages, hospital gowns) to complex instruments that help save and sustain life (heart valves, artificial pancreas). They include tools that aid in the detection of disease (MRIs [magnetic resonance imaging], in vitro diagnostics) and digital technology that is driving a revolution in health care (medical apps, surgical planning tools, closed loop drug delivery devices). [...] Although medical devices provide great benefits to patients, they also present risks. FDA's public health responsibilities span the life cycle of medical devices and, at every stage, FDA must make well-supported regulatory decisions, taking into account the totality of the evidence, to determine whether the benefits outweigh the risks."
United States. Food and Drug Administration
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FDA's Technology Modernization Action Plan (TMAP)
From the Document: "Recent scientific and biomedical advances--from genomic sequencing to development of cell and gene therapies and nanotechnologies-- have brought the promise of significant improvements to the health of many millions of Americans. To date, however, we have seen little of this promise in our day-to-day lives because a large and persistent gap separates important scientific advances and the technologies needed to translate those advances into new therapies for patients and new ways to protect the public health. The FDA's Technology Modernization Action Plan (TMAP), described in this document, is an important step FDA is taking to address and close this gap. The plan describes important near-term actions that FDA is taking to modernize use of technology-- computer hardware, software, data, and analytics--to advance FDA's public health mission. TMAP has three elements: (1) modernization of FDA's technical infrastructure; (2) enhancing FDA's capabilities to develop technology products to support its regulatory mission; and (3) communication and collaboration with stakeholders to drive technological progress that is interoperable across the system and delivers value to consumers and patients."
United States. Food and Drug Administration
2019-09-18
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Fact Sheet for Healthcare Personnel: STERIS Sterilization Systems for Decontaminating Compatible N95 Respirators
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of decontaminated, compatible N95 respirators. These compatible N95 respirators have been decontaminated using the 'STERIS N95 Respirator Decontamination Cycle (Non-Lumen Cycle) in STERIS V-PRO 1 Plus, VPRO maX, and V-PRO maX2 Sterilizers' (hereafter referred to as 'decontaminated N95 respirators' and 'STERIS Sterilization System' throughout this Fact Sheet)."
United States. Food and Drug Administration
2020-04-09
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FDA's Annual Financial Report: Fiscal Year 2002
From the Deputy Commissioner of the Food and Drug Administration: "I present to you the Food and Drug Administration's (FDA) Annual Financial Report for fiscal year (FY) 2002. I am pleased to report that FDA has earned its fifth consecutive 'clean' opinion on its audited financial statements. By comparing the fiscal information from these statements with the summary performance information reported under the Government Performance and Results Act, FDA is able to demonstrate how this investment yields valuable results. After the events of September 11, 2001, protecting our homeland has become more important than ever before. As the nation's foremost consumer safety organization, FDA strives to assure a safe food supply through critical science-based prevention strategies; ensures medical product safety and their use by millions of Americans; brings safe and effective new technologies to a world-wide market; and monitors emerging hazards through surveillance systems and monitors about eight million import shipments that enter the United States. Additional FY 2002 resources allowed FDA to facilitate the availability of new bioterrorism tools accelerating the availability of medical products necessary for public health preparedness and to strengthen its surveillance, investigational, and laboratory support for detection and management of product contamination for foods, medical products, and blood."
United States. Food and Drug Administration
2003?
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Chief Financial Officer's Annual Report: Fiscal Year 2001
From the Principal Deputy Commissioner of the Food and Drug Administration: "I present to you FDA's Chief Financial Officer's Annual Report for Fiscal Year 2001. I am pleased to report that the Agency has earned its fourth consecutive 'clean' opinion on its audited financial statements. By comparing the fiscal information from these statements with the summary performance information reported under the Government Performance and Results Act, taxpayers will realize that FDA is a good investment that yields valuable results. Fiscal Year 2001 brought change to FDA. The DHHS [Department of Health and Human Services] Secretary, Tommy Thompson, announced a series of long-term initiatives to make the Department more efficient and effective. These initiatives support the President's Management Agenda announced during the middle of the year. The results should be an improved administrative infrastructure sup-porting a more responsive citizen-focused workforce."
United States. Food and Drug Administration
2002?
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Chief Financial Officer's Annual Report: Fiscal Year 2000
From the Principal Deputy Commissioner of the Food and Drug Administration: "I present to you the Food and Drug Administration's (FDA) annual financial report for fiscal year (FY) 2000. I am pleased to report that FDA has earned its third consecutive 'clean' opinion on its audited financial statements. By comparing the fiscal information from these statements with performance information reported under the Government Performance and Results Act, taxpayers will realize that FDA is a good investment and that the dollars we spend yield valuable results. As a science-based regulatory agency, FDA's mission affects the health and well being of all Americans. FDA is responsible for overseeing a regulated industry that produces over $1 trillion worth of products. Whether at home, or at work or at play, FDA shields us from public health hazards that range from debilitating to the deadly. FDA protects consumers and consumers trust FDA. Surveys show that FDA's good work performance is recognized both by the public and regulated industries, and this performance is accomplished at the low annual cost of about $4 per person."
United States. Food and Drug Administration
2001?
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Vaccines and Biologics: Meeting Product Development Needs to Better Address Bioterrorism
Power point presentation at the American Enterprise Institute on vaccines and biologics. Outlines major issues in vaccine development against bioterrorism.
United States. Food and Drug Administration
Goodman, Jesse L.
2002-06-27
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Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff
From the Introduction: "The Food and Drug Administration (FDA or the Agency) 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 a policy to help expand the availability and remote capabilities of infusion pumps and their accessories for health care professionals during the COVID19 pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act."
United States. Food and Drug Administration
2020-04
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Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
From the Introduction: "The Food and Drug Administration (FDA or Agency) is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency. On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of COVID-19 cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness. This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States."
United States. Food and Drug Administration
2020-03-16
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FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards
From the Introduction: "FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic. Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR [code of federal regulations] 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices. In general, FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited."
United States. Food and Drug Administration
2020-03
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Latest COVID-19 Information from the FDA [website]
From the Website: "'Along with other federal, state, and local agencies and public health officials across the country, the FDA continues critical work to protect public health during the COVID-19 [coronavirus disease 2019] pandemic.'" This website contains various COVID-19 resources from the FDA.
United States. Food and Drug Administration
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Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff
From the Introduction: "The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including 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 a policy to help expand the availability of ventilators as well as other respiratory devices and their accessories during this pandemic."
United States. Food and Drug Administration
2020-03
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[Letter from Denise M. Hinton to Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators; Health Care Personnel; Hospital Purchasing Departments and Distributors; Importers and Commercial Wholesalers; and Any Other Applicable Stakeholders, March 28, 2020]
From the Letter: "On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19 [Coronavirus Disease 2019]. Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared on March 2, 2020, that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the Coronavirus Disease 2019 (COVID-19) outbreak, subject to the terms of any authorization issued under that Section."
United States. Food and Drug Administration
Hinton, Denise M.
2020-03-28
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FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards [Updated on April 16, 2020]
From the Introduction: "The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic. [...] This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act."
United States. Food and Drug Administration
2020-04-16
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Emergency Use Authorization: Face Masks
From the Document: "On April 18, 2020, in response to concerns relating to insufficient supply and availability of face masks, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) authorizing the use of face masks for use by members of the general public, including health care personnel (HCP) in healthcare settings as personal protective equipment (PPE), to cover their noses and mouths, in accordance with Centers for Disease Control and Prevention (CDC) recommendations, to prevent the spread of the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the Coronavirus Disease 2019 (COVID-19) pandemic, pursuant to section 564 of the Federal, Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3)."
United States. Food and Drug Administration
Hinton, Denise M.
2020-04-24
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Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry
From the Introduction: "Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA or Agency) has received a number of queries concerning compounding of alcohol-based hand sanitizers. The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this guidance as compounders) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. In light of the public health emergency posed by COVID-19, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate."
United States. Food and Drug Administration
2020-03
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Fact Sheet for Healthcare Personnel: Sterilucent Sterilization System for Decontaminating Compatible N95 Respirators
From the Document: "You have been given a N95 or N95-equivalent respirator ('compatible N95 respirator') that has been decontaminated for single-user reuse by healthcare personnel in a healthcare setting to help prevent exposure to pathogenic biologic airborne particulates during the COVID-19 [coronavirus disease 2019] pandemic. This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of decontaminated, compatible N95 respirators."
United States. Food and Drug Administration
2020-04-20
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Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
From the Introduction: "FDA 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 a policy to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the emergence of this rapidly spreading, severe illness. This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States."
United States. Food and Drug Administration
2020-05-11
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Fact Sheet for Healthcare Personnel: Stryker Sustainability Solutions Decontamination System for Decontaminating Compatible N95 Respirators
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of decontaminated, compatible N95 respirators. These compatible N95 respirators have been decontaminated using Stryker Sustainability Solutions' (SSS) VHP [vaporized hydrogen peroxide] N95 Respirator Decontamination System (hereafter referred to as 'decontaminated N95 respirators' and 'SSS Decontamination System,' respectively, throughout this Fact Sheet). Decontaminated N95 respirators that have been decontaminated using the SSS Decontamination System are authorized for multiple-user reuse by healthcare personnel in a healthcare setting during the COVID-19 [coronavirus disease 2019] pandemic."
United States. Food and Drug Administration
2020-05-27
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FDA Combating COVID-19 with Medical Devices
From the Document: "Since the beginning of the COVID-19 [coronavirus disease 2019] pandemic, FDA has been working to facilitate the development and availability of medical products and equipment for use by patients, physicians and healthcare systems as expeditiously and safely as possible."
United States. Food and Drug Administration
2020-05-25
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FDA Combating COVID-19 with Therapeutics
From the Document: "Since the beginning of the COVID-19 [coronavirus disease 2019] pandemic, the FDA has been working to facilitate development and availability of therapeutics for use by patients, physicians and health systems as expeditiously and safely as possible. In order to facilitate the development of potential COVID-19 treatments FDA created the Coronavirus Treatment Acceleration Program (CTAP), a new program designed to expedite the development of potential COVID-19 therapies by using every tool at the agency's disposal to determine if the therapies are safe and effective for their intended uses. Several therapies are currently being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19."
United States. Food and Drug Administration
2020-05-11
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Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (Revised)
From the Introduction: "FDA [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 communicate its temporary policy for the compounding of certain human drug products for hospitalized patients by outsourcing facilities that have registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b)."
United States. Food and Drug Administration
2020-05-21
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Memorandum of Understanding between FDA and USDA Regarding the Potential Use of the Defense Production Act with Regard to FDA-Regulated Food During the COVID-19 Pandemic
From the Purpose: "The purpose of this Memorandum of Understanding (MOU) is to describe the intended roles of, and working relationship between, the U.S. Department of Health and Human Services, Food and Drug Administration ('HHS-FDA' or 'FDA') and the U.S. Department of Agriculture ('USDA') (together the 'Parties'), with respect to the potential use of the Defense Production Act ('DPA') and oversight of those involved in the production of human and animal food other than facilities under USDA's exclusive jurisdiction during the public health emergency caused by the outbreak of COVID-19 within the United States. In particular, this MOU establishes a process in which FDA and USDA will communicate and make determinations about circumstances in which USDA could exercise its authority under the DPA with regard to certain domestic food resource facilities that manufacture, process, pack, or hold foods, as well as to those that grow or harvest food. This MOU does not apply to food resource facilities under USDA's exclusive jurisdiction."
United States. Food and Drug Administration
2020-05-18
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Compra De Comestibles Durante La Pandemia Del COVID-19 - Información Para Los Consumidores
"La compra de comestibles sigue siendo una necesidad durante esta pandemia y muchas personas tienen preguntas sobre cómo hacer sus compras de manera segura. Queremos asegurarles a los consumidores que actualmente no existe evidencia de que los alimentos para humanos o animales, o los envases donde se empacan los alimentos estén asociados con la transmisión del coronavirus que causa el COVID-19. Este coronavirus en particular causa una enfermedad respiratoria y se propaga de persona a persona, a diferencia de los virus gastrointestinales transmitidos por alimentos, como el norovirus y la hepatitis A, que a menudo enferman a las personas a través de alimentos contaminados."
United States. Food and Drug Administration
2020-04
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COVID-19 Information for Consumers -- Shopping for Food
From the Document: "As grocery shopping remains a necessity during this pandemic, many people have questions about how to shop safely. We want to reassure consumers that there is currently no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19 [coronavirus disease 2019]. This particular coronavirus causes respiratory illness and is spread from person-to-person, unlike foodborne gastrointestinal or GI viruses, such as norovirus and hepatitis A that often make people ill through contaminated food."
United States. Food and Drug Administration
2020-04
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What to Do If You Have COVID-19 Confirmed Positive or Exposed Workers in Your Food Production, Storage, or Distribution Operations Regulated by FDA
From the Document: "The Food and Agriculture Sector is designated as critical infrastructure, and it is essential that these operations continue during the pandemic. Workers are the backbone of this critical infrastructure, and we are providing this information to ensure employers have information to help support their workers and protect their health. This summary, derived from Centers for Disease Control and Prevention (CDC) recommendations, outlines key steps that employers and workers can take to help stay open, prevent and slow the spread of COVID-19 [coronavirus disease 2019], and support continuity of essential operations if workers are diagnosed with or exposed to COVID-19, or show symptoms associated with COVID-19. Links to more detailed practices and recommendations are also included."
United States. Food and Drug Administration
2020-04
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Fact Sheet for Healthcare Providers: Siemens Healthcare Diagnostics Inc. ADVIA Centaur® SARS-CoV-2 IgG (COV2G)
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the ADVIA Centaur® SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] IgG (COV2G) assay."
United States. Food and Drug Administration
2020-07-31
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Fact Sheet for Healthcare Providers: Siemens Healthcare Diagnostics Inc. Atellica® IM SARS-CoV-2 IgG (COV2G)
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Atellica® IM SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] IgG (COV2G) assay."
United States. Food and Drug Administration
2020-07-31
