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Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology,...more
This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance of the U.S. Food & Drug Administration...more
In a Memorandum Opinion, Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, vacated a U.S. Department of Health and Human Services (HHS) Final Rule, just days before its July 9 effective date. The...more