FDA has achieved a new milestone, Yesterday the U.S. Food and Drug Administration announces the Uses of investigational Convalescent plasma therapy as a treatment of COVID-19.
FDA has issued the Emergency Use Of Authorization (EUA) for Convalescent plasma treatment as a potential treatment on COVID-19 hospitalized patients. Based on available scientific evidences the U.S. FDA has decided to use plasma therapy treatment for the COVID-19 patients.
For this action, the U.S. food and drug administration has taken a lot of testing in the past several months and base on science and data generated from testing the FDA concluded to start an emergency treatment on patients. But Still, clinical trials are going in to demonstrate the safety and efficacy of convalescent plasma treatment.
The EUA authorizes the distribution of COVID-19 convalescent plasma in the US and its administration and its healthcare providers, as appropriate to treat the suspected or confirmed COVID-19 cases throughout hospitalizes patients in the USA.
The US Food and Drug Administration commissioner is committed to releasing and uses for the treatment of this convalescent plasma that;
Based on the evaluation of EUA criteria and available scientific data the USFDA's Center for Biologics Evaluation and Research (CBER) determined the criteria for issuing the EUA criteria were met.
As there is no alternative is available for COVID-19 treatment, FDA is started to use it. The agency also determined the known and potential benefits as well as potential risks. As there is no conformity about safety and effectiveness the concern is still remains.
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FDA Issues Emergency Use Authorization for Convalescent Plasma treatment
FDA has issued the Emergency Use Of Authorization (EUA) for Convalescent plasma treatment as a potential treatment on COVID-19 hospitalized patients. Based on available scientific evidences the U.S. FDA has decided to use plasma therapy treatment for the COVID-19 patients.
For this action, the U.S. food and drug administration has taken a lot of testing in the past several months and base on science and data generated from testing the FDA concluded to start an emergency treatment on patients. But Still, clinical trials are going in to demonstrate the safety and efficacy of convalescent plasma treatment.
The EUA authorizes the distribution of COVID-19 convalescent plasma in the US and its administration and its healthcare providers, as appropriate to treat the suspected or confirmed COVID-19 cases throughout hospitalizes patients in the USA.
What FDA Commissioner Said on Convalescent Plasma?
The US Food and Drug Administration commissioner is committed to releasing and uses for the treatment of this convalescent plasma that;
I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said Dr. Hahn. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus
Based on the evaluation of EUA criteria and available scientific data the USFDA's Center for Biologics Evaluation and Research (CBER) determined the criteria for issuing the EUA criteria were met.
As there is no alternative is available for COVID-19 treatment, FDA is started to use it. The agency also determined the known and potential benefits as well as potential risks. As there is no conformity about safety and effectiveness the concern is still remains.
What Alex Azar: Health and Human Services Secretary Said?
The US health and human services secretary has said that US President Donald trump's effort milestone achievement to save US citizen's lives from COVID-19.
The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19,” said Secretary Azar. “The Trump Administration recognized the potential of convalescent plasma early on. Months ago, the FDA, BARDA, and private partners began work on making this product available across the country while continuing to evaluate data through clinical trials. Our work on convalescent plasma has delivered broader access to the product than is available in any other country and reached more than 70,000 American patients so far. We are deeply grateful to Americans who have already donated and encourage individuals who have recovered from COVID-19 to consider donating convalescent plasma.
Mayo Clinical Expanded Program
The FDA Initially facilitated access to convalescent plasma for treating COVID-19 by using traditional clinical trial and emergency single-patient investigational new drug (IND) application.
The FDA for convalescent plasma was initiated expanded access program in early Apr 2020 to fill an urgent need to provide access to the medical product of possible benefit during a time that the FDA was working with researchers to initiate randomized clinical trials to study Convalescent plasma. As the number of single patients, IND requests started to number in the hundreds on daily basis. The FDA worked collaboratively with Industry, Academic and govt. partners to implement an expanded access protocol to provide convalescent plasma to the patients in need across the country via national expanded access treatment protocol.
The US FDA is responsible for public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccine, and other biological products for human use, and medical devices also.
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