Dit is hoe president Biden erover denkt:
November 11 2020
In January 2021, President-elect Biden will assume office and begin the transition to new leadership in the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). Without question, a focus on Coronavirus Disease 2019 (COVID-19) vaccines, treatments, and new technologies to identify, cure, and reduce the transmission of the virus will continue to be of paramount importance to President-elect Biden, as these matters were the centerpiece of his campaign. This GT Alert will also address additional changes in the broad areas of drugs, medical devices, biologics and foods, with a special emphasis on emerging technologies (especially through the Emergency Use Authorization (EUA) process), dietary supplements, remote patient monitoring/telehealth, and vaccines.
COVID-19 FDA Efforts (Vaccines)
President-elect Biden has taken action to confront the COVID-19 pandemic. He announced a COVID-19 task force made up of physicians and health experts. The three co-chairs include: Dr. Vivek Murthy, surgeon general during the Obama administration; Dr. David Kessler, FDA commissioner under Presidents Bush and Clinton; and Dr. Marcella Nunez-Smith, associate dean for health equity research at Yale University. The early goals of the task force are to work with state and local health officials on a plan to address the virus and its racial disparities and to develop a plan for reopening schools and businesses.
The key to the strategy includes the FDA EUA authority and ensuring that products going through this process have sufficient safety and efficacy prior to use in the market. Currently, there are several vaccines, therapies, lab tests, and other products either on the market or currently subject to EUA review. President-elect Biden could extend the Public Health Emergency (PHE) (currently set to expire on Jan. 21, 2021) in order to continue work to expedite review of these FDA products to the marketplace, and until such time as vaccines have been distributed and administered and a significant reduction in COVID-19 cases.
Vaccines and COVID-19 treatments are a priority for President-elect Biden. Dr. Janet Woodcock, an experienced leader in the FDA’s Center for Drug Evaluation and Research, is now working solely on accelerating vaccines and treatments for COVID-19.