![]() On Thursday, the FDA issued a safety communication to warn consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. The granting of these De Novo requests for Ortho-Clinical Diagnostics, Inc., is the latest example of the FDA’s ongoing commitment to maintain access to tests related to COVID-19. On Friday, the FDA granted the first marketing authorizations for serology COVID-19 tests using a traditional premarket review process. Hearing before the Health Subcommittee of the House Committee on Energy and Commerce Commissioner Robert Califf, M.D. Preparing for and Responding to Future Public Health Security Threats Food and Drug Administration will remain engaged with numerous activities to protect and promote public health. While the HHS public health emergency is ending, COVID-19 remains a high priority and the U.S. Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies Today, the FDA updated information on medical device shortages on the FDA.gov website to reflect the end of the COVID-19 public health emergency (PHE), including providing answers to questions. Today, the FDA updated its new Rumor Control page to provide the facts and inform the public on how the growing spread of rumors, misinformation and disinformation about science, medicine and the FDA is putting patients, consumers and their families at risk. On Monday, the FDA and the Veterans Health Administration announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics. Paxlovid is the fourth drug-and first oral antiviral pill-approved by the FDA to treat COVID-19 in adults. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. ![]() requested the voluntary withdrawal of the EUA for this vaccine.įDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults On Thursday, the FDA revoked the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine. This test is the first at-home over-the-counter (OTC) test for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness. ![]() The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection. View webcast.įDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review ProcessįDA granted marketing authorization for the Cue COVID-19 Molecular Test. This discussion will include consideration of the vaccine composition for fall to winter, 2023-2024. The committee will discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. Vaccines and Related Biological Products Advisory Committee The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. The FDA posted information regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons. Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023 ![]() On Thursday, the FDA re-issued two temporary guidances originally published during the COVID-19 public health emergency (PHE) for certain regulatory requirements that involve onsite visits abroad under the FDA Food Safety Modernization Act (FSMA). ![]()
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