Coronavirus (COVID-19) | CBER-Regulated Biologics

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as manufacturing efforts.</p> <p>Throughout the COVID-19 public health emergency, CBER worked on multiple fronts to address the pandemic, such as:</p> <ul> <li>Expedited clinical trials for preventive vaccines and other therapeutic biological products that held promise to prevent or treat COVID-19 by providing timely advice and interactions</li> <li>Supported product development and scale up of manufacturing capacity for high priority products for COVID-19</li> <li>Helped to ensure an adequate blood supply</li> <li>Provided information to healthcare providers and researchers to help them submit emergency IND requests to use investigational products to treat patients with COVID-19</li> </ul> <p><strong>If you are developing or interested in developing a CBER-regulated product</strong> to treat or prevent COVID-19, including a vaccine, cellular product, or blood-derived product, this page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance. </p> <p><strong>If you are not a product developer</strong> and are looking for general information on FDA and coronavirus response efforts, you can review materials provided on <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="87418b51-450e-43fa-8277-698ae515477f" href="/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19" title="Coronavirus Disease 2019 (COVID-19)">FDA鈥檚 COVID-19 website</a>. </p> <div class=" panel-group" id="accordion_960931" role="tablist" aria-multiselectable="true"> <div title="COVID-19 Vaccines" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674532a1e9c4c"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674532a1e9c4c" aria-controls="674532a1e9c4c">COVID-19 Vaccines</a> </h2> </div> <div id="674532a1e9c4c" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674532a1e9c4c"> <div class="panel-body"> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="9a120f96-c259-4631-ad96-eb034be7846f" href="/vaccines-blood-biologics/industry-biologics/information-about-updated-covid-19-vaccines" title="Information About the Updated COVID-19 Vaccines">Information About the Updated COVID-19 Vaccines</a></h4> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d734d09e-b386-4622-942c-ece164a2fd04" href="/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024" title="Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024">Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024</a></h4> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="fe3ac79c-6c17-45f6-9753-0682c65dd919" href="/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/pfizer-biontech-covid-19-vaccine" title="Pfizer-BioNTech COVID-19 Vaccine">Pfizer-BioNTech COVID-19 Vaccines</a></h4> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f0271c11-535a-4ade-9663-5518939cdaeb" href="/media/167781/download?attachment" title="Pfizer-BioNTech COVID-19 Vaccine decision memos and regulatory documents ">Pfizer-BioNTech COVID-19 Vaccine decision memos and regulatory documents</a></p> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="6fe7b4c3-82b2-4742-aa93-a54f16a419eb" href="/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/moderna-covid-19-vaccine" title="Moderna COVID-19 Vaccine">Moderna COVID-19 Vaccines</a></h4> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f0d4ef2a-9b0e-4961-a4ec-a24cbe327cc7" href="/media/167784/download?attachment" title="Zip File: Moderna COVID-19 Vaccine decision memos and regulatory documents ">Moderna COVID-19 Vaccine decision memos and regulatory documents</a></p> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="17282140-8db3-4536-a0ed-83983e74953b" href="/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/janssen-covid-19-vaccine" title="Janssen COVID-19 Vaccine">Janssen COVID-19 Vaccines</a></h4> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="07861074-543c-461c-9f18-49f456ece37d" href="/media/167786/download?attachment" title="Zip File: Janssen COVID-19 Vaccine decision memos and regulatory documents ">Janssen COVID-19 Vaccine decision memos and regulatory documents</a></p> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5036a6f6-4147-402f-a631-1cf2bc8e3b8e" href="/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/novavax-covid-19-vaccine-adjuvanted" title="Novavax COVID-19 Vaccine, Adjuvanted">Novavax COVID-19 Vaccine, Adjuvanted</a></h4> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="fc44fb6e-7766-42e1-9a61-c48f14225203" href="/media/167787/download?attachment" title="Zip File: Novavax COVID-19 Vaccine, Adjuvanted decision memos and regulatory documents">Novavax COVID-19 Vaccine, Adjuvanted decision memos and regulatory documents</a></p> </div> </div> </div> <div title="Archived Fact Sheets for COVID-19 Vaccines" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674532a1ea36d"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674532a1ea36d" aria-controls="674532a1ea36d">Archived Fact Sheets for COVID-19 Vaccines</a> </h2> </div> <div id="674532a1ea36d" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674532a1ea36d"> <div class="panel-body"> <p>The following Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers) and Vaccine Information Fact Sheets for Recipients and Caregivers for the vaccines have been archived but remain available for each vaccine for export in accordance with the applicable Letter of Authorization:</p> <h4>Moderna COVID-19 Vaccine</h4> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="61bac188-0d74-467f-8b47-c25c67bfac31" href="/media/167192/download?attachment" title="Archived Fact Sheets for Healthcare Providers, Recipients and Caregivers, including translations - Moderna">Archived Fact Sheets for Healthcare Providers, Recipients and Caregivers, including translations</a></p> <h4>Novavax COVID-19 Vaccine, Adjuvanted</h4> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5d0db8f0-68d1-4cc7-b1e7-7aacaae04e45" href="/media/172720/download?attachment" title="Archived Fact Sheets for Healthcare Providers, Recipients and Caregivers, including translations - Novavax COVID-19 Vaccine, Adjuvanted">Archived Fact Sheets for Healthcare Providers, Recipients and Caregivers, including translations</a></p> <h4>Pfizer-BioNTech COVID-19 Vaccine</h4> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5a72b081-effc-4271-b701-bdc2951adb75" href="/media/167193/download?attachment" title="Archived Fact Sheets for Healthcare Providers, Recipients and Caregivers, including translations - Pfizer-BioNTech">Archived Fact Sheets for Healthcare Providers, Recipients and Caregivers, including translations</a></p> </div> </div> </div> <div title="Contacts for Questions About Product Development" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674532a1ea3f2"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674532a1ea3f2" aria-controls="674532a1ea3f2">Contacts for Questions About Product Development</a> </h2> </div> <div id="674532a1ea3f2" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674532a1ea3f2"> <div class="panel-body"> <p>If you are developing a CBER-regulated product and have questions, CBER鈥檚 Division of Manufacturers Assistance and Training in the Office of Communication, Outreach and Development (<a href="mailto:Industry.Biologics@fda.hhs.gov">Industry.Biologics@fda.hhs.gov</a>, 240-402-8010, or 800-835-4709) can provide additional information or answers to questions that can help you prepare your submission and ensure that it contains the necessary information to facilitate review.</p> <p>If you are uncertain about CBER center or office assignment for your product, please contact: <a href="mailto:CBERProductJurisdiction@fda.hhs.gov">CBERProductJurisdiction@fda.hhs.gov</a></p> </div> </div> </div> <div title="CBER-Regulated Therapeutics and the Coronavirus Treatment Acceleration Program (CTAP)" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674532a1ea478"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674532a1ea478" aria-controls="674532a1ea478">CBER-Regulated Therapeutics and the Coronavirus Treatment Acceleration Program (CTAP)</a> </h2> </div> <div id="674532a1ea478" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674532a1ea478"> <div class="panel-body"> <p>CBER-regulated therapeutic products fall within FDA鈥檚 <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="93685e5a-21ef-4c5e-b35f-9b7c54411646" href="/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap" title="Coronavirus Treatment Acceleration Program (CTAP)">Coronavirus Treatment Acceleration Program</a> (CTAP). Please note that for products under CBER鈥檚 jurisdiction, submission to the CTAP mailbox helps to facilitate identification and assignment to the appropriate review office within our Center so that your inquiry gets to the right subject matter experts quickly.  Although we are working diligently to expedite the development of multiple promising vaccine candidates to the greatest extent possible, preventive vaccines are not included within CTAP and submissions or inquiries regarding preventive vaccines should not be submitted to the CTAP mailbox.</p> <p><strong>As a general matter, if your product is already assigned to CBER for another intended use or you have been in contact with CBER staff regarding your CBER-regulated product, please do not submit any additional inquiries or materials to the CTAP mailbox.  Such submissions are not necessary <em>and may result in unnecessary delays in processing your information</em>.</strong> Once a product has been assigned to a CBER office, all future communications regarding that product should be directed to the responsible review office point of contact, or, once your review team is established, to your assigned regulatory project manager. </p> <p>Do not submit regulatory documents (e.g., pre-INDs, INDs, emergency IND, or EUAs) for CBER-regulated products to the CTAP Mailbox. Instructions for these submissions are provided below.</p> <p>In particular, in the case of emergency single patient INDs (eINDs) for all CBER-regulated products other than convalescent plasma, please call 240-402-8010 or 800-835-4709 or email <a href="mailto:industry.biologics@fda.gov">industry.biologics@fda.gov</a>. After working hours, call FDA's Office of Emergency Operations at 1-866-300-4374 or 301-796-8240. For information on the process for submitting eINDs for convalescent plasma, please see <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="88f1821a-0f61-4cf8-9031-0fbbd64ca2d9" href="/vaccines-blood-biologics/investigational-new-drug-applications-inds-cber-regulated-products/recommendations-investigational-covid-19-convalescent-plasma" title="Recommendations for Investigational COVID-19 Convalescent Plasma">Recommendations for Investigational COVID-19 Convalescent Plasma</a>. Failure to follow these processes may delay review of your eIND and possibly delay access for your patient.</p> <p>For unapproved products, please note that your product may not be distributed for clinical use in humans until there is an IND in effect.</p> </div> </div> </div> <div title="COVID-19 Convalescent Plasma" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674532a1ea4ec"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674532a1ea4ec" aria-controls="674532a1ea4ec">COVID-19 Convalescent Plasma</a> </h2> </div> <div id="674532a1ea4ec" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674532a1ea4ec"> <div class="panel-body"> <p>One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19. On August 23, 2020 FDA issued an <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="bc36bb33-a1c3-41e4-8eb4-7e42d78ada97" href="/media/141477/download?attachment" title="Convalescent Plasma EUA Letter of Authorization">Emergency Use Authorization (EUA)</a> for COVID-19 Convalescent Plasma. In addition, the <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="88f1821a-0f61-4cf8-9031-0fbbd64ca2d9" href="/vaccines-blood-biologics/investigational-new-drug-applications-inds-cber-regulated-products/recommendations-investigational-covid-19-convalescent-plasma" title="Recommendations for Investigational COVID-19 Convalescent Plasma">Recommendations for Investigational COVID-19 Convalescent Plasma</a> page provides information on the pathways available outside of the EUA for administering or studying the use of COVID-19 convalescent plasma. It is critical to continue to enroll and complete randomized clinical trials to fully answer the questions about the effectiveness of convalescent plasma.</p> <p>Please note that FDA does not collect COVID-19 convalescent plasma or provide COVID-19 convalescent plasma. Health care providers or acute care facilities should obtain COVID-19 convalescent plasma from an FDA-registered blood establishment.</p> <p>Individuals who have fully recovered from COVID-19 may be able to help patients currently fighting the infection by donating your plasma. </p> </div> </div> </div> <div title="Emergency Use Authorization" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674532a1ea54c"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674532a1ea54c" aria-controls="674532a1ea54c">Emergency Use Authorization</a> </h2> </div> <div id="674532a1ea54c" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674532a1ea54c"> <div class="panel-body"> <h2>Emergency Use Authorization</h2> <p>Under an <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="16d8d1b0-6593-4914-941d-26b0225c5d0c" href="/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization" title="Emergency Use Authorization">Emergency Use Authorization</a>, FDA may permit the use of unapproved medical products or unapproved uses of approved medical products in certain emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives. We encourage applicants to submit any questions to <a href="mailto:CBEREUA@fda.hhs.gov">CBEREUA@fda.hhs.gov.</a></p> <h3>COVID-19 Convalescent Plasma</h3> <p>On August 23, 2020 FDA issued an <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="bc36bb33-a1c3-41e4-8eb4-7e42d78ada97" href="/media/141477/download?attachment" title="Convalescent Plasma EUA Letter of Authorization">Emergency Use Authorization (EUA)</a> for COVID-19 Convalescent Plasma. A summary of updated evidence to support the emergency use of COVID-19 Convalescent Plasma is available <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="245c1148-1e60-43ca-966d-d1a903491581" href="/media/142386/download?attachment" title="Evidence Supporting CP Emergency Use 092320">here</a>.</p> <h3>COVID-19 Vaccines</h3> <p>In October 2020, FDA issued guidance on Emergency Use Authorizations for Vaccines to Prevent COVID-19 with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19. In addition to outlining our expectations for vaccine sponsors, we also hope the agency鈥檚 guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.</p> <p>In addition, on October 22, 2020, <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e63a5d44-8cd9-4989-a41b-4575e9fccdaf" href="/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-22-2020-meeting-announcement" title="Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement - 10/22/2020">FDA鈥檚 Vaccine and Related Biological Products Advisory Committee</a> met in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application was discussed at this meeting. FDA intends to convene an open session of the VRBPAC upon submission of an EUA for a COVID-19 vaccine in order to publicly discuss the safety and efficacy of the particular vaccine.</p> <h3>EUA Transparency</h3> <p>We believe that transparency about CBER鈥檚 review of the scientific information supporting our recommendations to issue <a href="/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs">EUAs</a> for COVID-19 <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="93685e5a-21ef-4c5e-b35f-9b7c54411646" href="/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap" title="Coronavirus Treatment Acceleration Program (CTAP)">therapeutics</a> and vaccines promotes public confidence in FDA鈥檚 scientific review process and ultimately in using the authorized products appropriately.</p> <p>Therefore, our goal is to be as transparent as possible about the scientific basis for recommending that a biological product be authorized for emergency use under section 564 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360bbb-3) or be revised or revoked. In addition to convening FDA鈥檚 VRBPAC regarding COVID-19 vaccines:</p> <ul> <li>When a CBER-regulated product is authorized for emergency use, we intend to the extent appropriate and permitted by law to make public the Center鈥檚 review of the scientific data and information supporting our recommendation to issue the EUA</li> <li>When an EUA is revised, we also intend to make public the Center鈥檚 review of the scientific data and information supporting our recommendations to revise the EUA</li> </ul> <p>Our goal is to disclose information from our EUA review documents as appropriate and consistent with our longstanding practice of posting scientific reviews after product approvals. We may redact certain information that is exempt from disclosure under the Freedom of Information Act (FOIA), 5 U.S.C. sec. 552, such as trade secrets or other information identified by the EUA requestors that is exempt under FOIA. The redacted information may vary depending on the type of data contained in the reviews and whether the requestor consents to release of information that is exempt under FOIA.</p> </div> </div> </div> <div title="Pharmacovigilance for COVID-19 Vaccines" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674532a1ea5aa"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674532a1ea5aa" aria-controls="674532a1ea5aa">Pharmacovigilance for COVID-19 Vaccines</a> </h2> </div> <div id="674532a1ea5aa" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674532a1ea5aa"> <div class="panel-body"> <p>There have been tremendous efforts made in the development of vaccines for COVID-19 since the beginning of the public health emergency. As with all vaccines and other medical products, although the vaccine development process and FDA鈥檚 evaluation are rigorous and comprehensive, after a vaccine for COVID-19 is authorized under EUA by FDA, or following licensure (approval) of a BLA, additional pharmacovigilance will be conducted to monitor COVID-19 vaccine safety and effectiveness. Planning for this begins prior to authorization or licensure.  </p> <p>FDA and CDC recognize the need for significant effort in the pharmacovigilance area. Plans for pharmacovigilance include coordination with other Federal Partners. Many other state, or local government and other entities have a part to play in this effort domestically, as do other international groups.  </p> <p>CBER has posted an <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="40537984-8155-4c5a-a0e2-636205968a55" href="/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance" title="COVID-19 Vaccine Safety Surveillance">overview of the systems</a> in use to monitor the safety of COVID-19 vaccines. </p> <p>CBER is coordinating the response to COVID-19 vaccine pharmacovigilance inquiries from these stakeholders, across stakeholders, which will help to facilitate consistent and coordinated approaches. If you are an entity engaged in the evaluation of safety or effectiveness related to COVID-19 vaccines and have questions about pharmacovigilance, please contact us at: <a href="mailto:ocod@fda.hhs.gov">ocod@fda.hhs.gov</a>.</p> </div> </div> </div> <div title="Resources and Information" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674532a1ea604"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674532a1ea604" aria-controls="674532a1ea604">Resources and Information</a> </h2> </div> <div id="674532a1ea604" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674532a1ea604"> <div class="panel-body"> <p>CBER鈥檚 <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e0182cbb-aac0-4166-9b80-87dc114558a1" href="/vaccines-blood-biologics/resources-you-biologics/industry-biologics" title="Industry (Biologics)">webpage</a> has information about the regulatory framework for products regulated by CBER, including the Center鈥檚 policies, procedures, and review resources that may be helpful in answering questions you have about developing a CBER-regulated product. </p> <p>CBER has provided information for sponsors, applicants and regulated entities on steps the Center has taken to prioritize work that advances the nation鈥檚 response to the COVID-19 pandemic. These steps seek to address the impact of the public health emergency on day-to-day operations in CBER and industry, while ensuring that government and private sector response efforts receive the highest priority. </p> <p>Important information provided to sponsors includes:</p> <ul> <li>Processing of Incoming Documents</li> </ul> <ul> <li>Conduct of Clinical Trials involving Medical Products</li> </ul> <ul> <li>Postmarket and Compliance Activities</li> </ul> <p>Details about each of these topics and more can be found in the letter posted on CBER鈥檚 website.</p> <h2>COVID-19 Related Guidance Documents</h2> <p>FDA has issued several guidance documents related to COVID-19, including several that are immediately in effect. For the latest information, please see the FDA鈥檚 COVID-19 Related Guidance Documents web page.</p> <h2>Additional FDA Resources</h2> <p>All FDA Centers are working together to help bring new products for COVID-19 to the American people. Sponsors who want to develop drugs, medical devices or diagnostics related to COVID-19 can visit the following web pages:</p> <ul> <li>COVID-19 Resources for Healthcare Professionals</li> <li>Center for Drug Evaluation and Research: <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f743cf93-edfb-49a5-8102-3e85010e66fb" href="/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs" title="Coronavirus (COVID-19) | Drugs">Coronavirus (COVID-19) | Drugs</a></li> <li>Center for Devices and Radiological Health: <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f2e670cb-4cf4-4d5b-88c0-4433ddade5f2" href="/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices" title="Coronavirus (COVID-19) and Medical Devices">Coronavirus (COVID-19) and Medical Devices</a></li> <li>FDA鈥檚 <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a0f3efd5-d974-49f9-9f4a-6b62e879cd1d" href="/emergency-preparedness-and-response/public-health-preparedness-and-response/coronavirus-disease-2019-covid-19" title="Coronavirus Disease 2019 (COVID-19)">Coronavirus Disease 2019 (COVID-19)</a> web page</li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="53fd68f3-487a-4c4a-8fca-83b39623808c" href="/media/168035/download?attachment" title="Letter for DSCSA exemptions for COVID-19 products after public health emergency">DSCSA Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Covered COVID-19 Products</a></li> </ul> </div> </div> </div> </div> <br> <br> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top" > <ul role="menu" 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