I mentioned CDERs Critical Path Innovation Meeting program in a previous post on pharmacogenomics as a venue for non-regulatory meetings on a wide variety of topics. The meetings are requested by external stakeholders who wish to hold collaborative discussions about science, tools and methods that may enhance drug development. During the meeting, CDER experts would provide general advice on how the method or technology might be used and any gaps the requesters might address. The program helps CDER stay informed about innovations in drug development and the discussions are non-regulatory, drug product independent, and non-binding on all participants. Guidance and policy documents are available on the program, along with additional information on the programs web page. The list of previous meetings is tantalizingly brief, listing only the meeting titles and no further information. Its last update was in late September 2018, as well, but according to the CPIM project manager Alicia Barbieri several meetings have been held since then and the topics list is being updated now. According to the program FAQ, requesters have the option to post their contact information; however, readers interested in any particular topic should contact CPIM to request contact with the topic requester.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2019 Katrina Rogers