As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although there was no single moment like the passage of the Affordable Care Act in 2010, there are numerous distinct events that will loom large in 2024 and beyond.
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CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule
FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference
FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software
FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices
The Drug Price Negotiation Program Faces Pushback from Private and Public Industry Participants
FDA Clarifies Approach to Pediatric Drug Development
Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway
FDA To Require Demonstration of Cybersecurity Safeguards for Pre-Market Submissions of Certain Medical Devices
Payor-Led Initiatives to Strengthen Mental Health Resources
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