What address should be used to send Drug Master Files to CBER?
Drug Master Files and Updates (when changes occur that might impact products) to Drug Master Files for CBER-regulated products should be sent to: FDA/CBER Document Control Center 1401 Rockville Pike, Suite 200N Rockville, MD 20852-1448 To submit electronically, please refer to the guidance entitled “Guidance for Industry, Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications,” which can be found at http://www.fda.gov/RegulatoryInformation/Guidances/ucm126959.htm.
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