Enhancing Transparency at the US Food and Drug Administration: Moving Beyond the 21st Century Cures Act
| Autor: | Michael Stebbins, Joshua M. Sharfstein |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
Medical device Device Approval Internet privacy Public policy Public Policy Disclosure 030226 pharmacology & pharmacy Food and drug administration Access to Information 03 medical and health sciences 0302 clinical medicine Agency (sociology) Medicine 030212 general & internal medicine Drug Approval health care economics and organizations Scientific enterprise business.industry United States Food and Drug Administration Public health General Medicine Transparency (behavior) United States business |
| Zdroj: | JAMA. 317(16) |
| ISSN: | 1538-3598 |
| Popis: | The US Food and Drug Administration (FDA) has primary responsibility for oversight of every drug, biologic, and medical device sold in the United States. Yet the FDA is far more than a regulator. It is also an agency dedicated to public health, with the expertise of thousands of scientists and access to enormous amounts of information from clinical trials and other studies. Greater transparency can allow FDA not only to better meet its many obligations but also to advance the scientific enterprise needed to develop safe and effective medical products. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|