Post by marriott on Nov 23, 2023 16:31:13 GMT
from FDA:
FDA issues final guidance on developing drugs for COVID-19 treatment and prevention
Today, FDA issued the final guidance COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. The guidance provides updated recommendations that reflect the evolving scientific knowledge and the current state of the pandemic. This supersedes the final guidance of the same name initially issued on May 12, 2020 and reissued on February 22, 2021.
Although the COVID-19 public health emergency has expired, SARS-CoV-2 continues to circulate, and COVID-19 remains a serious health risk for some individuals. There is a need to ensure that sponsors are aware of FDA’s recommendations on the development of drugs and biological products for treatment and prevention of COVID-19.
The guidance provides FDA’s current recommendations on the design of phase 2 and phase 3 trials with a focus on trial population and design, efficacy endpoints, as well as safety and statistical considerations. The guidance does not provide recommendations on the development of preventative vaccines, convalescent plasma, or Long COVID-19 as these development programs raise different considerations.
link: www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-developing-drugs-and-biological-products-treatment-or-prevention?utm_medium=email&utm_source=govdelivery
FDA issues final guidance on developing drugs for COVID-19 treatment and prevention
Today, FDA issued the final guidance COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. The guidance provides updated recommendations that reflect the evolving scientific knowledge and the current state of the pandemic. This supersedes the final guidance of the same name initially issued on May 12, 2020 and reissued on February 22, 2021.
Although the COVID-19 public health emergency has expired, SARS-CoV-2 continues to circulate, and COVID-19 remains a serious health risk for some individuals. There is a need to ensure that sponsors are aware of FDA’s recommendations on the development of drugs and biological products for treatment and prevention of COVID-19.
The guidance provides FDA’s current recommendations on the design of phase 2 and phase 3 trials with a focus on trial population and design, efficacy endpoints, as well as safety and statistical considerations. The guidance does not provide recommendations on the development of preventative vaccines, convalescent plasma, or Long COVID-19 as these development programs raise different considerations.
link: www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-developing-drugs-and-biological-products-treatment-or-prevention?utm_medium=email&utm_source=govdelivery