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Federal Food Drug and Cosmetic Act (FFDCA) Patient Access

Morgan Lewis - As Prescribed

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

Verrill on

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

Troutman Pepper Locke

Right to Try Legislation: Worthwhile or Window Dressing?

Troutman Pepper Locke on

"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more

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