“When COVID-19 was declared a national emergency, the Food and Drug Administration had to act quickly on its oversight responsibilities around the sudden need for new testing, equipment and, ultimately, vaccines. Especially in the face of new variants, the Center for Drug Evaluation and Research (CDER) is taking lessons learned during the pandemic to prioritize upcoming needs and areas of improvement.”
“One major way the department was able to scale up its processes was through its Coronavirus Treatment Acceleration Program (CTAP) launched in April 2020 to accelerate the development of therapeutics in collaboration with the Center for Biologics Evaluation and Research (CBER).”
“’As part of this program, we used all available tools to engage with developers and also to exercise regulatory flexibility to the full extent that we could,’ CDER Director Patrizia Cavazzoni said during FDA’s annual conference for industry regulatory education. ‘Early engagement and communication with our developers as well as regulatory flexibility’ was essential to the launch and success of CTAP, she added.”
“To date, CDER has authorized 10 COVID-19 treatments for emergency use under the program, with more than 620 drug development programs in planning stages and more than 460 trials of potential therapies reviewed.”
“’These are novel treatments, so this gives you an idea of how fast the development played itself out, and we are really talking about developing drugs in a matter of months rather than years,’ Cavazzoni said…” Read the full article here.
Source: How FDA Ramped Up COVID-19 Treatment Approvals – By Sarah Sybert, July 26, 2021. GovernmentCIO.
