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Carol Cooper, RAC

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United States
Board of Directors

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1 to 5 of 49 total

RE: Electronic Package Inserts for US Market for IVD products

Posted By Carol Cooper 08-Feb-2024 11:09
Found In Egroup: Regulatory Open Forum \ view thread
Yes, the FDA does allow for electronic IVD PIs. As the manufacturer, one must have a documented procedure for swiftly sending the paper IVD information upon request. There is one concern which is not all labs have use of the internet. Therefore this situation when the employer prevents use, it may ...

Homeopathic Products

Posted By Carol Cooper 30-Apr-2022 11:03
Found In Egroup: Regulatory Open Forum \ view thread
Was asked a question regarding formulation of homeopathic drug products. There is a draft guidance from CBER and CDER available, but few details provided. ------------------------------ Carol Cooper RAC Principal Libertyville IL United States ------------------------------

RE: off label case study - conference

Posted By Carol Cooper 19-Mar-2021 09:50
Found In Egroup: Regulatory Open Forum \ view thread
This is a sticky question, perfect for a Friday. There are many details missing, for there is an allowance for discussing design requirements for medical devices prior to market. So here are some additional questions: 1. Was the company speaker in medical or scientific affairs? 2. Was it at a ...

Dietary Supplements Consultant for Australia

Posted By Carol Cooper 24-Aug-2020 13:08
Found In Egroup: Regulatory Open Forum \ view thread
Hello, US manufacturer wishing to sell dietary supplements in Australia. Looking for a US based consultant.  Regards, Carol ------------------------------ Carol Cooper RAC Principal Libertyville IL United States ------------------------------

RE: Urgent help - Guidance: Export "ban"/restrictions of some Covid-19 medical devices out of China

Posted By Carol Cooper 22-Apr-2020 09:25
Found In Egroup: Regulatory Open Forum \ view thread
I can only speak for the IVDs and generalize what may be the reasons for the restrictions to export from China. First, the medical devices must actually work for the intended use(s) and there has been negligence, if not fraud on some device exports. The EU has recognized three IVDs for Emergency Use ...