The FDA has recently published a notice soliciting input from interested parties on the topic of Type V Drug Master Files for Model Master File Submission to support ANDAs. The initial thoughts of the RS Community Regulatory Response Committee members is that while there may be isolated experiences, our community does not have a suggested best practice to suggest. The results of a workshop conducted on the topic in 2022 were published in the AAPS journal (Fang et al. AAPS Journal 26(2):28-35.
If you would think that the RS Community should respond, please let Vasudev Bhupathi and myself know promptly what comments are needed.
The call for comments is attached.
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Joan Korth-Bradley
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