Draft Guidance Covers Using URRAs in Combo Product Applications July 10, 2024 A use-related risk analysis (URRA) can be used in all phases of the medical product lifecycle. Read More
Third Alzheimer’s Drug Gets FDA Approval, Just as Diagnostic Criteria Expand July 10, 2024 The new diagnostic criteria automatically categorize anyone with abnormal levels of beta amyloid or tau as having Alzheimer’s disease. Read More
Three Device Areas Added to CDRH’s Device-Advancing TAP Program July 9, 2024 CDRH launched the TAP Pilot in 2023 as a commitment under the MDUFA V reauthorization. Read More
Risk of 10 Obesity-Driven Cancers Reduced by GLP-1s, Study Says July 9, 2024 The findings strongly suggest that these drugs may have a place in cancer prevention. Read More
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