FDA published a Q&A document to respond frequently asked questions from submitters and applicants on regulatory matters and issues relating to medical devices arising from the COVID-19 public health emergency.
This guidance addresses the following:
- Meetings with Industry
- MDUFA Goals and Timelines
For more details, please see the original document from the FDA.
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
Table of Contents
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This article provides general information and does not constitute regulatory, legal, clinical, or compliance advice. Requirements and appropriate processes may vary by study, product, jurisdiction, and organization. Medigen Suite functionality should be used in accordance with applicable regulations, study documentation, and internal procedures.
