Today the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) updated its Coronavirus Treatment Acceleration Program (CTAP) webpage and posted a FDA Voices article on the program. This special emergency program for possible therapies uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.
During the COVID-19 public health emergency FDA has been working closely with other agencies, as well as industry to develop a coordinated and swift response. In order to effectively facilitate this work it’s important that we periodically reassess processes. For example, as of April 16, 2020, FDA received 950 inquiries and proposals concerning COVID-19 related drug development. Because the overriding objective is to develop safe and effective treatments for American patients as soon as possible, the strongest proposals will be prioritized for review based on the scientific merits of the proposal. CDER will post more information concerning CTAP procedures and timelines on the webpage as it becomes available.
Relatedly, the National Institutes of Health (NIH) announced a public-private partnership to speed COVID-19 vaccine and treatment options. NIH and the Foundation for NIH are bringing together more than a dozen leading biopharmaceutical companies, the Biomedical Advanced Research and Development Authority, Centers for Disease Control and Prevention, U.S. Food and Drug Administration, and European Medicines Agency to develop a national strategy for a coordinated research response to the COVID-19 pandemic. Collaboration is a critical ingredient for success in addressing this pandemic. FDA looks forward to participating in this effort and will continue to use every tool possible to speed the development of safe and effective medical countermeasures. |
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