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Federal Pilot Programs Patient Access

Carlton Fields

Agency Actions, Trade Deals, and Other Initiatives to Further Executive Order Goals for the Pharma Industry

Carlton Fields on

The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more

Hogan Lovells

FDA’s ‘Project Facilitate’ Pilot to Collect Metrics on Sponsor Expanded Access Denials

Hogan Lovells on

This morning, FDA announced it launched its new expanded access pilot called “Project Facilitate,” a concierge call center under the Oncology Center of Excellence (OCE) to facilitate the Single Patient IND (SPI) request...more

Sheppard Mullin Richter & Hampton LLP

Federal Regulatory Developments Brewing in Telehealth

Two federal agencies – the Centers for Medicare and Medicaid Services (“CMS”) and the Federal Communications Commission (“FCC”) – announced separate initiatives last week that stand to increase patient access to telehealth...more

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