General Resources on COVID-19

FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative: Summary Report – This report reflects highlights of the agency’s response, accomplishments and activities and describes a broad set of potential prospective actions that the agency could consider going forward.

COVID-19 Information from FDA  – The latest updates, announcements, and guidance from the U.S. Food and Drug Administration (FDA)

COVID-19 Vaccines - The FDA has regulatory processes in place to facilitate the development of COVID-19 vaccines that meet the FDA's rigorous scientific standards.

COVID-19 Vaccines for Children and Teens- The CDC now recommends everyone age 5 or older get a COVID-19 vaccine. 

FDA FAQs – FDA answers frequently asked questions about food, medical treatment, vaccines, devices, and veterinary products amid the COVID-19 pandemic

NIH Updates – News and resources from the National Institutes of Health

CDC Updates – News and weekly surveillance report from the Centers for Disease Control and Prevention (CDC)

HHS Updates – COVID-19 information from the U.S. Department of Health and Human Services

COVID-19 Pandemic Resources – Public and technical updates, including travel advice, from the World Health Organization (WHO)

Global Research on COVID-19 – Links to clinical trials around the world  

Diagnostic Tests for COVID-19  Information on tests available for detecting SARS-CoV-2 and a list of organizations offering testing and/or test kits

Glossary of Terms – A list of common terms and definitions related to drug development and expanded access

Resources for Patients and Caregivers
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COVID patient

 

FDA Grand Rounds – FDA webinar on "Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve?"

FDA Resources for Patients – Resources to help patients and caregivers cope with the COVID-19 pandemic

COVID-19 Educational Resources – Videos, toolkits, podcasts, consumer articles, and more from FDA

FDA Voices –  FDA’s Center for Devices and Radiological Health’s unprecedented efforts in the COVID-19 response

Hand Sanitizers and COVID-19  Answers from FDA on common questions about hand sanitizer and antibacterial soap 

Hand Sanitizer and Safety  FDA information regarding use of hand sanitizer and hygiene for consumers 

CDC COVID-19 Homepage – Latest information from the CDC 

How to Protect Yourself – Tips on how to protect yourself and what to do if you're sick   

Know the Symptoms   List of symptoms and a self-checker 

Patients & Caregivers Guide to Expanded Access – Detailed guide to help patients and caregivers understand the process of accessing investigational drugs when a clinical trial is not an option

CDC's COVID-19 Parental Resources Kit – CDC's parental guidance for serving children and young people's mental health challenges and well-being

UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus   FDA provides answers to consumers’ questions about the use of UV lamps for disinfection during the COVID-19 pandemic

Resources for Healthcare Providers
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Healthcare provider


Actemra (tocilizumab) EUA – FDA Authorizes the drug Actemra (tocilizumab) for Treatment of COVID-19

Antiviral drug Veklury (remdesivir)  FDA Approves First Treatment for COVID-19

Blood Purification Device Authorized  FDA authorizes blood purification system to treat patients 18 and older with COVID-19

Chloroquine and Hydroxychloroquine  FDA revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine

Convalescent Plasma  –  FDA issues guidance for industry on use and collection of convalescent plasma

Convalescent Plasma EUA –  FDA issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID-19 treatment

Convalescent Plasma EUA Revision – FDA updates Emergency Use Authorization for COVID-19 Convalescent Plasma to reflect new data

Coronavirus Treatment Acceleration Program (CTAP)  Special emergency program created by FDA to expedite the availability of potentially safe and effective life-saving treatments

COVID-19 Communication Toolkits - Materials and messages from the FDA about COVID-19 to communicate with patients, the public, and health care professionals

Emergency Use Authorizations (devices) – Lists current and terminated EUAs that make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies

Emergency Use Authorization (all) – Lists all current EUAs, including drugs and biologics

Expanded Access Navigator Guide for Healthcare Providers – Detailed guide to help physicians and healthcare providers request and manage access to  investigational treatments outside of a clinical trial

Guidance for IRBs and Clinical Investigators  Institutional Review Board (IRB) Review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency

Guidance for Industry –  FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development

Guidance for Industry, Investigators, and Institutional Review Boards – FDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency

Hospital Beds, Stretchers, and Mattresses FDA FAQs to address questions related to design, evaluation, labeling, and marketing 

Laboratory Safety Guidance on workflow safety concerns of laboratory personnel during the COVID-19 pandemic

Management of Healthcare Workers Exposed to COVID-19 –  CDC's guidance for Public Health Management of Healthcare Workers Exposed to or with Suspected or Confirmed COVID-19: non-U.S. Healthcare Settings

Medical Devices and the COVID-19 Pandemic – Information from FDA on diagnostic tests, ventilators, and personal protective equipment (PPE), including masks, face shields, respirators, gowns, and gloves

Medical Gloves for COVID-19 Information from FDA on manufacturing, purchasing, importing, and donating gloves during the public health emergency

Monoclonal Antibodies – FDA issues an Emergency Use Authorization for Monoclonal Antibodies (bamlanivimab and etesevimab) for treatment of COVID-19

SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests – FDA information regarding the impact of viral mutations on COVID-19 tests, recommendations for clinical laboratory staff and health care providers, and information about certain tests for which the FDA has identified potential impacts on performance due to SARS-CoV-2 genetic mutations. The FDA will update this page as significant new information becomes available and includes: Background on SARS-CoV-2 viral mutations; General information for clinical laboratory staff and health care providers; Specific molecular tests impacted by viral mutations and recommendations for those tests.

Testing Healthcare Personnel for SARS-CoV-2  CDC summary of considerations and recommendations regarding testing healthcare personnel (HCP) for SARS-CoV-2.

Treatment Guidelines  NIH key updates to COVID-19 treatment guidelines

Treatment Summary Recommendations  NIH recommendations for care of critically ill patients with COVID-19

UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus   FDA provides answers to consumers’ questions about the use of UV lamps for disinfection during the COVID-19 pandemic

 

COVID-19 Vaccines:

CDC COVID-19 Vaccine Recipient Education Toolkit – These materials include proven communication strategies and tips for effectively setting expectations and addressing questions from COVID-19 vaccine recipients

Moderna COVID-19 Vaccine – FDA issues Emergency Use Authorization for the Moderna COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine – FDA issues Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine Update – FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents (12-15 Years of Age)

Pfizer-BioNTech COVID-19 Vaccine Update – FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

Pfizer-BioNTech COVID-19 Vaccine Booster Update – FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

Pfizer-BioNTech COVID-19 Vaccine FDA Approval – FDA Approves Pfizer-BioNTech COVID-19 Vaccine and will be marketed as Comirnaty

USP COVID-19 Vaccine Handling Toolkit – Provides critical information to accelerate delivery and support safe handling of COVID-19 vaccines for pharmacists, doctors, nurses, nurse practitioners, physician assistants, health profession students, and others

 

Personal Protective Equipment:

FDA Insight – FDA publishes new podcast titled “Personal Protective Equipment and COVID-19"

Mask and Gown Shortage FAQs Answers to frequently asked questions on shortages of surgical masks and gowns

Masks and N95 Respirators – Information about the use of N95 vs surgical or face masks

Medical Devices and the COVID-19 (Coronavirus) Pandemic  Information from FDA on diagnostic tests, ventilators, and personal protective equipment (PPE)—including masks, face shields, respirators, gowns, and gloves

Medical Glove Conservation Strategies  Letter from FDA to health care providers on potential shortages of surgeons' gloves and patient examination gloves

PPE basics  CDC's overview of who should use PPE and how to use it

PPE Conservation  Strategies to conserve PPE and other resources

Surgical Mask and Gown Conservation Strategies  Letter from FDA to health care providers recommending conservation strategies for a range of need and supply levels

Filtering facepiece respirators Letter from FDA to healthcare providers advising that certain filtering facepiece respirators from China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19