Health Care Law News and Insights

On April 18, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced plans to roll-out a new approval pathway for rare disease drugs. Commissioner Makary's comments build on sentiments expressed across both the patient community and industry that rare disease drug development needs greater regulatory flexibility in order to speed access...

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On April 15, President Trump signed an Executive Order reviving a previous directive to reduce the cost of insulin and injectable epinephrine for low income individuals. The Executive Order instructs the Secretary of U.S. Department of Health and Human Services (HHS) to require federally qualified health centers (FQHC) to offer 340B program...

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On March 31, the U.S. District Court for the Eastern District of Texas issued a significant opinion in the case of ACLA et al. v. FDA.1 This case was brought by laboratory organizations challenging a final rule released by the FDA last year, which aimed to regulate laboratory-developed tests (LDTs) as medical devices under the Federal...

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