CVM will present a one-hour webinar to answer questions posed by industry. CVM will answer questions previously submitted by industry. Please submit all follow up questions you have during the webinar via the chat box function.
Friday, March 27th
Online registration is closed.
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The following questions were submitted to CVM:
Questions related to ongoing studies
- What actions should be taken to continue ongoing studies if the quality monitoring of critical study phase is disrupted?
- How will CVM address some of the challenges regarding the studies such as remote monitoring and QA review during in-life of the study, reduced enrollment, extended study enrollment period, missed study visits by owners, or missed observations by limited clinic staff?
- FDA published guidance on “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.” What aspects of the recently issued FDA guidance ‘FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic’ will be applicable to animal health clinical trials?
- What considerations will CVM make concerning missing data in both proof of concept and pivotal studies due to restricted travel?
- For studies in client owned animals, what allowance will CVM accept if clients are unable to bring their animals in for regularly scheduled visits? These would include implementation of remote case evaluations by phone or video, rather than having the protocol prescribed visits in person.
- How can CVM and sponsors work together to mitigate risk?
- Where is CVM currently planning to use enforcement discretion? i.e. BIMO inspections
Questions related to site visits and inspections
On March 18th, Commissioner Hahn announced all domestic inspection will be cut back and international inspections were previously stopped.
- What effect will this have on sponsors?
- What is the FDA current positions on conducting study site visits by Sponsors for pivotal studies planned or in progress, PV or GMP inspections?
- This would be extremely important information for all companies to know as many will have restrictions about visitors entering facilities (to maintain a disease-free environment) and thus may lead to inspectors conducting unannounced regulatory inspections from regulatory authorities being simply refused access.
- We have heard that ORA will utilize recent inspections done by other countries to maintain function of foreign sites. Can a similar process be done for animal products?
- How will CVM handle necessary face to face interactions between different offices and with industry e.g. method trial demonstrations?
Questions about CVM review and government services
- How will this situation effect CVM’s review of submissions?
- Does CVM foresee any possible disruptions in the new animal drug or generic animal drug review/approval process under ADUFA/AGDUFA?
- What percent of resources are now being diverted to planning for/evaluating/managing risk of COVID-19 which are being taken away from conducting business as usual?
- Do you anticipate any change in personnel as the agency shifts focus to the COVID-19 response?
- Is CVM expected to have any reduction in workforce during the current restrictions?
- How is CVM utilizing the information provided by sponsors on the potential for shortages to take a risk-based approach to reviews?
- For example, are certain items moving up in the queues to avoid potential disruptions (particularly for CMC supplements)?
- Will there be delays in review of submissions (protocols) that are part of an RCC project?
- Will FDA continue to process export certificate applications if they are working from home?
- How are staffing issues at the ports, specifically CBP impacting the supply chain as shipments take longer to clear and/or are refused entry?
Questions about Coordination
- Has there been coordination with the European authorities? Several of the questions asked by regulators are the same in both markets. There may be efficiencies to be gained through close collaboration with EMA.
- How can FDA/CVM support actions needed to declare Animal Health manufacturing and supply chain as essential services regarding exemption from any potential mandatory lock-down/shut-out of workers re Covid-19 control rules?”
- AHI recently sent the attached comments to DHS to support animal health as an essential service.