From your description, it sounds like an "AI Response" was provided on the 182nd day. In this case, the submission is automatically withdrawn by the system and there is nothing the FDA can do to prevent the withdrawal. It has even happened to companies that were not aware of postal holidays and winter weather that prevented their submission from being ...

Good morning, The FDA has a guidance on aseptic filling for drugs/biologics - https://www.fda.gov/media/71026/download. While I recognize that your product is a device, it would seem most likely that the same principles would apply.  There is discussion there about what sampling and testing should be performed to demonstrate suitability of process ...

Yes. It is in fact not unusual to have the registration batches from one API lot. Registration batches are manufactured to demonstrate that the Drug Product can be made consistently. ------------------------------ Glen Park PharmD Executive Director, Regulatory Affairs and Quality Assurance Jersey City NJ United States ---------------------------- ...

1) IRBs generally do not receive the results of a clinical trial except for the required safety information. Even in the case of Phase 1 studies with one site, some of the data, such as pharmacokinetics of the drug, is not even available to the investigator since the samples are assayed at a different location. I don't see any conflict in this process ...

I would recommend three sources for submission to FDA: - FDA's 2005 Content of Premarket Submissions for Software Contained in Medical Devices, Page 9 - FDA's 2019 Off-the-Shelf Software Used in Medical Devices, Page 6 - FDA's 2014 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, page 6 It would also be be helpful ...