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Dear RA community, Can anybody suggest preferred vendor for eCTD templates catered towards cell and gene therapy INDs? I am looking for templates which comes with the instructions written for cell and gene therapy INDs, particularly for CMC sections. Most available eCTD templates have instructions ...

Dear RA community, Can anybody suggest preferred vendor for eCTD templates catered towards cell and gene therapy INDs? I am looking for templates which comes with the instructions written for cell and gene therapy INDs, particularly for CMC sections. Most available eCTD templates have instructions ...

I don’t think that’s even acceptable per regulatory standards. Even more so for autologus cell therapy products, when finished product sterility results won’t be available at the time of patient infusion of genetically modified cells. --------------------------------- Deep Shah, MS Global Regulatory ...

Hi Meena, My response from biologics perspective- I've found it very useful to follow the QbD approach when driven by the TPP and QTPP. It helps defining the CQAs, which later helps identifying the parameters that can influence the CQAs i.e., critical process parameters and developing design space ...

Dear RA professionals, Do we need to submit human factors data to the IND before introducing PFS or autoinjectors into registration trials? My current assumption is to submit the human factors data only in the BLA. Please advise. Many thanks for your time!  Best, Deep ------------------------------ ...