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FDA to sponsors: Early communication key during COVID-19

Posted 22 June 2020 | By Kari Oakes 

FDA to sponsors: Early communication key during COVID-19

Virtual meetings – a staple of business life during the COVID-19 pandemic – are an option for sponsors who seek meetings with the US Food and Drug Administration. Best routes of communication with the FDA both for coronavirus-related and other submissions and tips for having productive virtual meetings were shared with attendees of the virtual DIA 2020 global annual meeting by Khushboo Sharma, deputy director of operations at the Office of New Drugs at FDA’s Center for Drug Evaluation and Research.
Sharma provided some statistical background to frame CDER’s responsiveness, pointing out that the number of meetings granted has increased both numerically and as a percent of all meetings granted over time. Ordinarily, CDER receives over 3,000 formal meeting requests from industry. However, in the year to date, the agency has received about 1700. As of 21 May, CDER had received 258 COVID-19 pre-IND meeting requests. Of these, 82%, or 211, were type B meetings.
At present, the response time is less than six days from the receipt of the request for meeting, and just over 14 days from the time of the agency's response to the meeting being held.
Sharma said that FDA asks to be contacted as soon as possible when considering a COVID-19 related submission. the agency has created a scientific and technical triage team that is reviewing COVID-19 related inquiries and can provide feedback to ensure efficiency and completeness of any submissions. Given the large number of potential therapeutics, “the review process has to be as efficient as possible,” said Sharma.
Since there are many potential therapeutics for COVID-19 that may already be seeking approval for other indications, Sharma clarified that sponsors who already have an active IND should submit a new pre-IND meeting request for the new COVID-19 indication rather than amending the existing application. This request, along with any other submitted to
Regarding non COVID-19 virtual industry meetings, Sharma said that they are continuing to accept new meeting requests in granting request as has been the usual process for both PDUFA and MDUFA. Meetings are being scheduled as virtual when appropriate, although many discussions that formerly would have been held as face to face meetings are now being handled via written correspondence, said Sharma.
Best practices from the FDA point of view for these virtual meetings include sticking to the agenda. Also, in the virtual world, “if the meeting involves sensitive information, it is important that you confirm that only invited people are attending,” she said. It’s the sponsor’s responsibility to confirm with FDA that meeting invitees and participants can be involved in sensitive discussions.
“Be even more structured” in discussions, making sure to have clear objectives and know what the “ask” is out of the meeting, advised Sharma. The difficulty in picking up on non-verbal clues and reading body language means that words chosen must be crystal clear.
Housekeeping and best practices tips, such as muting the call when not speaking and using the “raise hand” or chat functions to let others know that there is a question or point of discussion, can facilitate the flow of a virtual meeting, she said.
“We are continuing to monitor the current public health emergency and evaluating the feasibility of conducting advisory committee meetings virtually,” said Sharma.  “Review divisions will work closely with applicants” in evaluating the feasibility of a virtual advisory committee, she said, adding that “We need to get buy-In from the applicant and the meeting chair,” and that efficient and early communication with all stakeholders is a necessary component of moving into these uncharted waters.
On 17 and 18 June, CDER held its first virtual advisory committee meeting, with members of the pediatric subcommittee of the Oncologic Drugs Advisory Committee meeting virtually for discussion with sponsors; there were no voting questions. The meeting was without significant technical hiccups, and offers promise for a future where the return to more face-to-face meetings is uncertain, said FDA.
“We want all of our stakeholders to have a chance to participate, and this is a good opportunity for us to use technology to balance the need for social distancing with maintaining transparency about the important work of the FDA,” said Patrizia Cavazzoni, MD, acting director of CDER. “The agency has successfully hosted webinars and training sessions remotely with many participants, and we are confident in our ability to take the next step to virtual advisory committee meetings. We are very pleased that we can continue our efforts to protect public health and help ensure that drugs are safe, effective and high quality during the COVID-19 pandemic.”


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Tags: Coronavirus, FDA, US

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