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 ...

Check out standards ISO13408 parts 1 & 2. Demonstrating sterility assurance levels is a bit more complicated for aseptic filling than for terminal sterilisation methods. I haven't had experience of submitting data for 510(k) for aseptic products so aren't sure exactly what is required by the FDA (my experience is more EU-based) but these standards should ...

Hi All.  Please can people share their experiences / recommendations and cost for appointing a European Representative?  I have performed some searches and unearthed a number of companies but I do not want to contact each one individually, I would like to rule out the good, bad and ugly before I go forward.  Thanks James ------------------------------ ...