FDA action on new EUAs, including an innovative ventilator developed in collaboration with NASA, consumer updates on pets, advice on drug supply, and more in the ongoing response to the COVID-19 pandemic. Preguntas más frecuentes acerca de la Enfermedad del Coronavirus 2019 (COVID-19) The FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the 2019 coronavirus (COVID-19) pandemic. The FDA is committed to providing timely advice to support response efforts to this pandemic. Coronavirus (COVID-19) Update: Fda takes action to protect public health; Increasing the supply of alcohol-based hand sanitizers The FDA recommends that the US include statements about whether non-clinical laboratory studies have been conducted in accordance with applicable Good Laboratory Practice (GLP) regulations31 and whether clinical trials have been conducted in accordance with applicable standards of good clinical practice.32 The FDA also recommends that: Specify the methods and quality systems used to improve the quality and integrity of data from animal studies submitted in support of an ITA application but not carried out under GLP. An essential part of the FDA`s work is to ensure the security of the U.S. food and medical supply during COVID-19. 7. Unless otherwise specified, the terms “Approved Product” and “FDA Approved Product” mean a product approved, authorized, or marketed pursuant to Sections 505, 510(k), or 515 of the FD&C Act or Section 351 of the PHS Act. For the purposes of this document, an “unapproved” product means a product that is not approved, authorized or offered for commercial distribution under sections 505, 510(k) or 515 of the FD&C Act or section 351 of the PHS Act; “Unauthorized use of an approved product” means a product that is approved, licensed or marketed under such a provision, but for which the specific use is not an approved, authorized or released use of the product.
See section 564(a)(2). To this end, the FDA has provided the pharmaceutical industry with clear communication from the outset about the scientific data and information needed for rapid vaccine development. And, among other things, the government has developed a coordinated strategy involving its own agencies, academia, nonprofits, and pharmaceutical companies to prioritize the development of the most promising vaccines. Coronavirus (COVID-19) Update: FDA provides guidance on making alcohol-based hand sanitizers to increase supply and protect public health Today, the FDA provided an update on its efforts to ensure the availability of alcohol-based hand sanitizers to meet the demand for hand sanitizer during the COVID-19 pandemic. FDA Updates on Ebola Preparedness and Response (all agency activities) Understanding regulatory terminology for COVID-19 prevention and potential treatments The FDA has taken steps to increase shipments to the U.S. to support the U.S. response to COVID-19 by providing instructions to manufacturers who import personal protective equipment and other equipment. Representatives from the FDA, NIOSH and OSHA will answer questions.
The FDA will hold a virtual public meeting for clinical laboratories and commercial manufacturers developing diagnostic tests for SAR-CoV-2. The objective of this town hall is to answer technical questions on the development and validation of tests for SARS-CoV-2. HHS officials testified at a Senate HELP hearing, An Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the novel coronavirus. The FDA is taking significant action in response to the coronavirus, granting Emergency Authorization (EUA) for the first diagnosis of novel coronavirus 2019 Section 564A allows the FDA to facilitate certain emergency activities with FDA-approved MCAs without an EUA. That authority shall be independent of the EEA authority in accordance with Section 564. To address concerns about potential violations of the FD&C Act in relation to mcM-related activities discussed in this section, the FDA has in the past either: (1) exercised its discretion in enforcing the activity; or (2) have issued an ITA to ensure that the use of these MCAs continues to fall within the otherwise applicable protection of PREP61 (discussed in Section VII of this Guide). MCAs used under this authority are eligible for the applicable protection of the PREP Act.62 Coronavirus (COVID-19) Update: The FDA reissues emergency authorizations and revises the types of respirators that can be decontaminated for reuse As with EUA applications, the FDA prioritizes its pre-EUA activities based on various factors. Many of them are discussed in more detail in section III.D.4.a of this Guide. Examples of additional factors that the FDA may consider when prioritizing activities prior to the EEA may include: progress against product development goals or milestones; concurrent FDA obligations or urgent circumstances (e.g., deadlines for user fees, other Agency priorities); and whether there is a high probability that the product will be retained in or added to government inventories if the product is approved for emergency use.
The scope and timing of review of these submissions will be determined on a case-by-case basis and will depend on the type of submission (e.g., whether an IND or IDE already exists for the product), the circumstances of the urgency, and the workload of the review staff. COVID-19: Update on progress towards a safe return to work and school. 29. For devices that are the subject of an IND or FDI or for which a permanent drug or device file is available, sponsors may refer to the relevant document containing that information, where appropriate with appropriate reference rights. The range of data available for unapproved products will vary considerably. The FDA recommends that any application for review of an EEA include available preclinical test data, such as in vitro and animal toxicological data. The FDA also encourages that human safety information from clinical trials and individual patient experiences be available, if available. The data submitted in the application should attempt to link the likely exposure to MCM to all existing relevant preclinical data. Similarly, where animal data are used, sufficient information shall be provided to correlate the results of these data with the expected exposure to MCAs associated with the proposed human use. Any safety information associated with the use of this compound or related products of a similar design in humans should also be provided.
Overview of the FDA`s Revised Antibody Testing Policy: Prioritizing Access and Accuracy Coronavirus (COVID-19) Update: FDA approves first stand-alone at-home sampling kit that can be used with some authorized tests Today, FDA released test performance data from four additional antibody or serology test kits on open.fda.gov of its independent performance validation study with the National Cancer Institute (NCI) of the National Institutes of Health (NIH) published. 49. If it is established that the translation of an information document into a foreign language is appropriate and necessary, the person carrying out the translation is responsible for the accuracy and completeness of the translation; The FDA does not intend to verify the accuracy of the translations. On December 23, 2014, the FDA granted Emergency Use Authorization (EUA) to approve the LightMix Ebola Zaire rRT-PCR Test for the suspected detection of Zaire Ebola virus in a whole blood preparation from individuals with signs and symptoms of Ebola virus disease. The test will only be performed on specified equipment from CLIA high-complexity laboratories or similarly qualified non-U.S. laboratories.