My company operates in the U.S., so why do I have to use MedDRA if the FDA has not made a ruling?
MedDRA is an international medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. Since November 1997, the FDA has replaced its Spontaneous Reporting System ( SRS ) and the Coding Symbols for Thesaurus of Adverse Reaction Terms ( COSTART © ) Terminology with the new Adverse Events Reporting System ( AERS ) and the MedDRA Terminology. The use of MedDRA is inevitable since the rule to mandate the use of MedDRA was in the OMB office and the 90-day review period was up in mid-November 2002. To date, the mandate regarding the use of MedDRA is still a part of the proposed rule for post-marketing reporting. Are there any FDA regulations or policies concerning the use of the primary System Organ Class (SOC) allocation of individual terms for adverse event reporting, for either pre-marketing or post-marketing reports? Is there any documentation to support this directive? Curre
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- My company operates in the U.S., so why do I have to use MedDRA if the FDA has not made a ruling?
