miércoles, 15 de julio de 2020

COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders | FDA

COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders | FDA





Information for industry

Health care providers
  • Home-Use Blood Glucose Meters Used in Hospitals and Long-Term Care Facilities During the COVID-19 Pandemic - FDA recognizes that home-use blood glucose meters may be used by patients with diabetes who are hospitalized due to COVID-19 or by those who reside in long-term care facilities (nursing homes, skilled nursing facilities, and assisted living facilities) to check their own blood glucose levels and provide the readings to the health care personnel caring for them. The FDA has updated these frequently asked questions to recognize that these devices may be used in long-term care facilities as well as hospitals. (July 10, 2020)
Biologics
  • Study of antibody response to SARS-CoV-2 spike proteins could help inform vaccine design - FDA scientists have identified specific areas on the so-called spike proteins on the surface of the COVID-19-casuing virus that appear to be key to triggering strong protective antibody responses in rabbits exposed to the virus. The virus uses one part of the spike protein to attach to a cell and another to fuse with the cell membrane, enabling the virus to infect the cell. The scientists studied antibody response to SARS-CoV-2 spike proteins, which could help inform vaccine design by increasing our understanding of the various triggered antibody responses. Also see the article in Science Translational Medicine (July 10, 2020)
The FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 50 COVID-19-related guidances to date.

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