FDA updates COVID-19 therapeutics website

Regulatory NewsRegulatory News | 14 July 2020 |  By 

The US Food and Drug Administration (FDA) has to date reviewed over 230 trials of potential therapeutics to treat the novel coronavirus (COVID-19), according to a blog post by FDA commissioner Stephen Hahn, MD and colleagues. Over 510 COVID-19-directed drug development programs have reached the planning stage.
In the blog, agency officials provide an update on FDA’s Coronavirus Treatment Acceleration Program (CTAP), a set of resources designed to allow cross-agency sharing of scientific resources and expertise in the quest for COVID-19 therapeutics. The CTAP webpage has been updated to highlight and provide context “about CTAP’s purpose, strategy and operations.”
A new dashboard on the CTAP webpage gives a visual readout of facts and figures related to the COVID-19 therapeutics in the development pipeline. The dashboard is expected to be updated monthly. The CTAP page, said FDA, also includes key guidances and links that are useful for not only for therapeutics developers and researchers, but also for patients and consumers.
As the pandemic blossomed and therapeutics developers began the race to find COVID-19 treatments, “The FDA recognized that there would be a need for early and frequent discussions between the agency and potential therapeutic product developers,” said Hahn and his colleagues. Accordingly, FDA set up an email address for those inquiring about COVID-19 therapeutics development.
A triage team at FDA monitors the inbox to route and track inquiries, with a goal of acknowledging receipt within 24 hours. Hahn and his colleagues said that clinical and scientific reviewers, together with policy experts and regulatory project managers, make sure that submitters have enough information in the received proposals “for productive discussion.” When enough information is gathered, the triage team routes the proposal, accompanied by an agency-crafted synopsis, to the appropriate FDA unit.
Less-experienced therapeutics developers receive additional outreach and support from reviewers and regulatory affairs experts at both CBER and CDER, who field preliminary inquiries before they are sent to product review teams in these cases.
The officials said that work is being done at speed, but within the existing regulatory framework. “For therapeutic development programs with strong rationales and evidence, we continue to dramatically exceed standard timelines,” they said.

Though the need for accelerated development is critical, skipping early steps in the pre-Investigational New Drug (IND) stage does not smooth the way, said Hahn and his colleagues: “We have found that a complete pre-IND submission is the key to expediting comprehensive pre-IND advice, more rapid review of the subsequent IND and more rapid clinical trial initiation."
Hahn coauthored the update together with Patrizia Cavazzoni, MD, Acting Director, Center for Drug Evaluation and Research (CDER) and Peter Marks, MD, Director, Center for Biologics Evaluation and Research (CBER).


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