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On this Page:
- Food and Drug Administration Safety and Innovation Act
- 21st Century Cures Act
- Understand FDA Regulatory Acronyms, Language and Terminology
- Drugs@FDA Glossary of Terms
- Patient Focused Drug Development (PFDD)
- Glossary of Terms about Clinical Trials
Food and Drug Administration Safety and Innovation Act (FDASIA)
Section 1137 of FDASIA, Patient Participation in Medical Product Discussions, directs the Secretary of Health and Human Services to: develop and implement strategies to solicit the views of...
21st Century Cures Act
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances...
Understand FDA Regulatory Acronyms, Language and Terminology
The FDA uses scientific, regulatory, and government agency acronyms, language and terminology. The Following database and glossaries are designed to help patients, caregivers...
Drugs@FDA Glossary of Terms
The glossary provides standardized language and terminologies related to drug development
Patient-Focused Drug Development Glossary
This glossary defines terms that will be used in the series of methodological Patient-Focused Drug Development (PFDD) FDA guidance documents that are required by the 21st Century Cures Act...
Glossary of Terms about Clinical Trials
FDA's Patient Affairs Staff (PAS) in partnership with the National Organization for Rare Disorders (NORD) is excited to host Patient Listening Sessions! Patient Listening Sessions are a resource...