Where can I find guidance for how master files can be used in the submission of information relevant to my combination product?
Guidance for Drug Master Files is available at http://www.fda.gov/cder/guidance/dmf.htm , and guidance for Drug Master File Binders is available at http://www.fda.gov/cder/ddms/binders.htm . Guidance for master files for biological products is available at http://www.fda.gov/cber/gdlns/dmfv.pdf . Guidance for master files for devices is available at http://www.fda.gov/cdrh/dsma/pmaman/appdxc.html . We have developed a new combination product and would like to initiate a dialogue with the appropriate FDA staff to obtain guidance on how to go about obtaining approval. However, we have limited experience in dealing with the FDA and do not know whom we should contact. Can the Office of Combination Products help? Yes. One of OCP’s functions is to help facilitate meetings between industry and the Agency for combination products. You can contact OCP by either e-mail (combination@fda.gov) or telephone (301-427-1934) and, based on the composition of your product and its intended use, a member o
Guidance for Drug Master Files and Drug Master File Binders, master files for biological products, and for master files for devices is available. We have developed a new combination product and would like to initiate a dialogue with the appropriate FDA staff to obtain guidance on how to go about obtaining approval. However, we have limited experience in dealing with the FDA and do not know whom we should contact. Can the Office of Combination Products help? Yes. One of OCP’s functions is to help facilitate meetings between industry and the Agency for combination products. You can contact OCP by either e-mail (combination@fda.gov) or telephone (301-427-1934) and, based on the composition of your product and its intended use, a member of our staff will work with you to identify the FDA staff with the appropriate scientific, clinical, and regulatory expertise to discuss your product, and to help organize and schedule the meeting.
