Unraveling the FDA's CNPV and Expedited Review Programs

Experts and former FDA staff call for reforms to FDA's National Priority Voucher program at public hearing

At a hearing, pharma companies and advocates weighed in on the program from former FDA commissioner Makary

Innovative Insights: Legal Updates in Life Sciences

CMS-1844-P, Home Health Fraud, and the Founder Opportunity: How Retroactive Revocations and Geographic Saturation Rules Turn Medicare Program Integrity Into a Buildable Market

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When Software Stopped Being a Lab Test: How the CY2027 OPPS Rule’s Software as a Medical Service Category, the O1 Status Indicator, and Pulling Lab AI Off the CLFS Reshape Health Tech Investing

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FDA's AI for Drug Approvals Found to Fabricate Studies

The FDA’s new AI designed to speed up drug approvals has been found to fabricate studies and misrepresent research. What do you think?

Threat in Your Medicine Cabinet: The FDA's Gamble on America's Drugs

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