U.S. Food and Drug Administration04.17.20
The U.S. Food and Drug Administration’s User Fee programs help us fulfill our mission to protect public health while also helping to accelerate innovation in industry and bring new treatment options to the American public. Throughout this public health emergency, we’ve continued to execute our review activities while responding to the public health needs of the current COVID-19 pandemic.
We continue to perform our user fee review activities and our application review teams across the agency remain focused on their work as we do everything possible to maintain continuity of operations in a very dynamic situation. Part of these actions include looking at ways to use technology and established agreements with our foreign counterparts to minimize impact to applications under review.
On the prescription drugs and biologics side, our Center for Drug Evaluation and Research and our Center for Biologics Evaluation and Research (CBER) staff are working diligently, both to address challenges with the ongoing outbreak and to carry out our on-going duty to safeguard public health while helping to ensure that safe and effective, high-quality drugs and biologics are available to the public. At this time, the New Drug Program, the Generic Drug Program, and the Biologics and Biosimilars Programs are continuing to meet key review program user fee performance goals, approve applications and communicate with applicants. With many staff working on COVID-19 activities, it is possible that we will not be able to sustain our current level of performance indefinitely. Our staffs are working at full capacity and we are striving to ensure that the drug programs continue to see minimal interruptions during this time. However, if there is an increase in drugs shortages and supply disruptions, we will be ready to reprioritize more of this work, as necessary.
On the devices side, our Center for Devices and Radiological Health (CDRH) and CBER continue to meet all of their Medical Device User Fee Amendments (MDUFA) review goals. We have taken steps to contact industry stakeholders to convert each previously scheduled meeting through May to a teleconference. For marketing applications on hold, we are further extending response due dates by 90 days for Premarket Notifications (510(k)s), Premarket Approval (PMA) applications (original and supplements), Humanitarian Device Exemption (HDE) applications (original and supplements) and De Novo classification requests. It is likely this extension of time will have an impact on the FDA and industry’s ability to meet the shared outcome goals for total time to decision as listed in the MDUFA IV commitment letter. Additionally, with many staff in CDRH working on COVID-19 activities related to pre-Emergency Use Authorizations (pre-EUAs), EUAs, and Immediately In Effect (IIE) guidance documents, it is possible that we will not be able to sustain our current level of performance indefinitely. However, this will be assessed on an ongoing basis.
For animal drug and generic animal drug user fee programs, our Center for Veterinary Medicine continues to meet all of its user fee-related performance goals and does not currently anticipate a change in our ability to meet these performance goals during the COVID-19 pandemic. Our staff is currently in a primarily telework environment and is utilizing teleconferencing tools to continue communicating with sponsors in lieu of in-person meetings. To help minimize the potential impact of the COVID-19 pandemic on new animal drug development, we issued guidance for industry stakeholders on the conduct and review of studies to support new animal drug development. We are also closely monitoring the potential for new animal drug shortages and supply chain disruptions, and we are working closely with sponsors to address these challenges, as appropriate.
It is difficult to speculate on what the exact impact will be on incoming submissions moving forward. We are seeing and hearing from industry that companies are taking a role as partners in the defense of the public health by prioritizing their work and submissions.
As this remains an evolving and very dynamic situation, the FDA will continue to be flexible and as transparent as possible as we work to address the COVID-19 pandemic, as well as keep other key mission-critical initiatives unrelated to the pandemic moving forward.
We continue to perform our user fee review activities and our application review teams across the agency remain focused on their work as we do everything possible to maintain continuity of operations in a very dynamic situation. Part of these actions include looking at ways to use technology and established agreements with our foreign counterparts to minimize impact to applications under review.
On the prescription drugs and biologics side, our Center for Drug Evaluation and Research and our Center for Biologics Evaluation and Research (CBER) staff are working diligently, both to address challenges with the ongoing outbreak and to carry out our on-going duty to safeguard public health while helping to ensure that safe and effective, high-quality drugs and biologics are available to the public. At this time, the New Drug Program, the Generic Drug Program, and the Biologics and Biosimilars Programs are continuing to meet key review program user fee performance goals, approve applications and communicate with applicants. With many staff working on COVID-19 activities, it is possible that we will not be able to sustain our current level of performance indefinitely. Our staffs are working at full capacity and we are striving to ensure that the drug programs continue to see minimal interruptions during this time. However, if there is an increase in drugs shortages and supply disruptions, we will be ready to reprioritize more of this work, as necessary.
On the devices side, our Center for Devices and Radiological Health (CDRH) and CBER continue to meet all of their Medical Device User Fee Amendments (MDUFA) review goals. We have taken steps to contact industry stakeholders to convert each previously scheduled meeting through May to a teleconference. For marketing applications on hold, we are further extending response due dates by 90 days for Premarket Notifications (510(k)s), Premarket Approval (PMA) applications (original and supplements), Humanitarian Device Exemption (HDE) applications (original and supplements) and De Novo classification requests. It is likely this extension of time will have an impact on the FDA and industry’s ability to meet the shared outcome goals for total time to decision as listed in the MDUFA IV commitment letter. Additionally, with many staff in CDRH working on COVID-19 activities related to pre-Emergency Use Authorizations (pre-EUAs), EUAs, and Immediately In Effect (IIE) guidance documents, it is possible that we will not be able to sustain our current level of performance indefinitely. However, this will be assessed on an ongoing basis.
For animal drug and generic animal drug user fee programs, our Center for Veterinary Medicine continues to meet all of its user fee-related performance goals and does not currently anticipate a change in our ability to meet these performance goals during the COVID-19 pandemic. Our staff is currently in a primarily telework environment and is utilizing teleconferencing tools to continue communicating with sponsors in lieu of in-person meetings. To help minimize the potential impact of the COVID-19 pandemic on new animal drug development, we issued guidance for industry stakeholders on the conduct and review of studies to support new animal drug development. We are also closely monitoring the potential for new animal drug shortages and supply chain disruptions, and we are working closely with sponsors to address these challenges, as appropriate.
It is difficult to speculate on what the exact impact will be on incoming submissions moving forward. We are seeing and hearing from industry that companies are taking a role as partners in the defense of the public health by prioritizing their work and submissions.
As this remains an evolving and very dynamic situation, the FDA will continue to be flexible and as transparent as possible as we work to address the COVID-19 pandemic, as well as keep other key mission-critical initiatives unrelated to the pandemic moving forward.
