Much to metabolize: The 21st Century Cures Act introduces numerous changes to FDA’s drug regulatory framework to spur development of new treatments

The 21st Century Cures Act (Cures Act) has become law with measures designed to deliver new cures and treatments to patients.  Among these measures are a broad range of changes to the U.S. Food and Drug Administration’s regulation of drugs and biologics. This alert highlights key areas of the Cures Act that will affect pharmaceutical and biotechnology companies, including provisions related to clinical trials, use of real world evidence, patient-focused drug development, health care economic information, summary level review, combination products, expanded access, drugs for rare diseases, and regenerative therapies.

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