Coronavirus Disease 2019 (COVID-19) updates Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last email update include: Bookmark www.fda.gov/coronavirus for the latest. | COVID-19 vaccine updates Additional batch of Janssen COVID-19 vaccine released FDA authorized (PDF) the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. To date a total of four batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management. (July 2, 2021) COVID-19 vaccines safety and diversity videos Diverse researchers and scientists who mirror the diversity in our communities have been developing vaccines to help protect us from COVID-19. Learn why you and your loved ones should get vaccinated as soon as a vaccine is available to you in this FDA video (1:22) in English and American Sign Language. This video is also available in: Spanish, Korean, and Navajo. | | | Drug approval milestone In late June 2021, FDA reached a milestone of approving 1,000 original and supplemental generic drug applications to help in the treatment of patients with COVID-19 since the start of the pandemic. The Center for Drug Evaluation and Research prioritized the review of generic drug applications for potential treatments and supportive therapies for patients with COVID-19, such as antibiotics, sedatives used in ventilated patients, anticoagulants, and pulmonary medications. Reaching this milestone during the COVID-19 pandemic further supports the FDA's everyday mission of improving access to safe, high-quality treatment options, which can result in more competition in the market and more affordable medicines for Americans. Upcoming events -
July 8, 2021: FDA Grand Rounds webcast - SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern, 12:00 - 1:00 p.m. ET - New! July 13, 2021: Webinar on Revocation of EUAs for Non-NIOSH-Approved Respirators and Decontamination Systems, 12:00 - 1:00 p.m. ET - FDA will host a webinar to share information and answer questions about revocation of EUAs for non-NIOSH-approved respirators and decontamination systems.
- July 14, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - FDA will host an additional webinar in this series on July 28. Note that log-in information for this series has changed, as of July 14, 2021.
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July 19-23, 2021: Regulatory Education for Industry (REdI) Annual Conference 2021 - Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA's regulatory requirements. The keynote speaker, Acting Commissioner Janet Woodcock, MD, will reflect on FDA's use of EUAs and other resources in making drug, device, and biological products available to support the public health response to the COVID-19 pandemic. -
Save the date! August 2-4, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens In case you missed it Find a COVID-19 vaccine near you Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. Learn more at vaccines.gov. | | | List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 250 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list. | | | Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity |
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