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    RE: Number of API Lots

    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 ...

  • Posted in: Florida Chapter

    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 ------------------------------ ...


Volunteer Appreciation 2019

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here

 

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