Clinical management and identification of respiratory diseases has become more rapid and increasingly specific due to widespread use of PCR(polymerase chain reaction) multiplex technologies. Although significantly improving clinical diagnosis, multiplexed PCR assays could have a greater impact on local and ...
/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the...
二、问题中提到的防疫物资在美国也是有不同的法规来管理,主要有以下种类: √个人防护设备:42 CFR Part 84 APPROVAL OF RESPIRATORY PROTECTIVE DEVICES (归口NOISH管理) √普通和塑料外科设备:21 CFR Part 878 GENERAL AND PLASTIC SURGERY DEVIC...
Thank you for your inquiry about the importation of respirators. The FDA is working diligently to mitigate potential shortages and has taken actions to help ensure that health care personnel (HCP) on the front lines have sufficient supplies ofrespiratoryprotective devices during the COVID-19 public...
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (...
Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. ABRYSVO is unadjuvanted an...
By the 2025-2026 respiratory virus season, FluMist, the nasal influenza vaccine, will be available for home vaccination via self- or caregiver-administration to eligible patients. As influenza season rapidly approaches, the FDA hasapproveda self-administered nasal spray influenza vaccine: ...
Postmarketing requirements for drugs, biologics, and devices 29 Q23. Reporting serious adverse events for approved drugs used to treat COVID-19 31 Q24. Reporting serious adverse events associated with COVID-19 in a non-COVID trial 32 Q25. Reviewing IND safety reports 33 Q26. Collecting ...
SILVER SPRING, Md.,July 17, 2023/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV ...
Although bronchial thermoplasty is designed to decrease the number of severe asthma attacks on a long-term basis, the procedure may cause a transient increase and worsening of respiratory-related symptoms that generally resolves within 7 days, using standard care. Other potential adverse effects may ...