Does Industry‐Conducted All‐Case Surveillance of Newly Approved Oncology Drugs Contribute to the Revision of Package Inserts in Japan?
In Japan, the Pharmaceuticals and Medical Devices Agency requires all‐case surveillance studies (ACSS) for many novel oncology drugs as a condition for approval. However, this is a major burden on the pharmaceutical industry and clinicians. The objective of this analysis was to investigate whether A...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2019-09-01
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| Series: | Clinical and Translational Science |
| Online Access: | https://doi.org/10.1111/cts.12644 |