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Congress Incentivizes Rare Disease Research. Big Pharma Exploits It. – Mother Jones

Loopholes in the Orphan Drug Act serve drug companies, not patients. ....

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A $2.8 Million Miracle Therapy Eludes Some Long-Suffering Patients

A $2.8 Million Miracle Therapy Eludes Some Long-Suffering Patients
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CDER Launches the ARC Program to Expedite Treatment Options for Rare Diseases | Wilson Sonsini Goodrich & Rosati

In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) announced the launch of a new program for expediting the development of. ....

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CDER Launches the ARC Program to Expedite Treatment Options for Rare Diseases

In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) announced the launch of a new program for expediting the development of new treatment options for rare diseases Accelerating Rare disease Cures (ARC) Program.1 The FDA considers a disease that affects fewer than 200,000 people in the U.S. a rare disease, and estimates that more than 30… ....

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