New FDA Program to Accelerate Coronavirus Treatments

Regulatory NewsRegulatory News | 31 March 2020 |  By 

The US Food and Drug Administration (FDA) on Tuesday detailed a new “special emergency program” for accelerating research and development of potential treatments for coronavirus disease (COVID-19).
Details about the program come as the US faces the world’s largest COVID-19 outbreak, with Johns Hopkins University reporting more than 180,000 confirmed cases and 3,600 deaths attributed to the virus.
Under the coronavirus treatment acceleration program (CTAP), FDA says it is responding to requests from researchers and industry as rapidly as possible and by providing “ultra-rapid, interactive input on most development plans.”
Now that it has worked through the initial wave of requests, FDA says it intends to respond to developers within a day and will try to conduct trial protocol reviews in some cases within 24 hours. The agency says it is also working with other federal agencies, drugmakers and researchers to develop study protocols “that can be used across institutions and programs to streamline efforts.”
In addition to responding to requests from developers and reviewing protocols, FDA says it is working “around-the-clock” to review single patient expanded access requests and is generally completing those reviews in three hours. FDA Commissioner Stephen Hahn said: “Accelerating the investigation of products that could potentially benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. We want to help patients by expediting promising treatments and are committed to maximizing our regulatory flexibility.”
FDA also says it has “worked closely with applicants and other regulatory agencies to expedite quality assessments for products to treat COVID-19 and to transfer manufacturing to alternative or new sites to avoid supply disruption.”
To support the program, FDA says it has redeployed medical, regulatory, operations and policy staff to assist in the effort and has involved senior management in its reviews.
According to FDA, there are 10 therapeutic agents in active clinical trials and another 15 products still in planning stages, although the specific products and companies are not mentioned due to commercial confidentiality issues.
However, FDA says it will update the page with summary statistics “to the extent permitted by confidentiality laws,” and link to public information regarding clinical trials and products in preclinical development.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy