Chapter 56 - Regulatory considerations for new drugs and devices
- Author(s)
- Chen, K; Lim, TP; Yuen, JSP; Ho, H; Murphy, DG;
- Journal Title
- In: Translational Urology, Eltorai, A. E. M., Arab,, A., Atala, A., Siddiqui, M. M. (eds)
- Publication Type
- Book section
- Abstract
- The old adage of “All things are poison and nothing is without poison” by the 15th Century Swiss Physician and Alchemist Paracelsus (c. 1493–1541) expresses the basic truth about the harmful nature of all drugs. To the general public, harm can manifest if there is no knowledge on the indication, dosage, and risk–benefit ratio of the vast expanse of drugs in the market. Even with professional medical advice, that risk is not entirely mitigated as the ultimate safety of the consumer goes beyond ensuring the right indication and dosage but encompasses a wider scope of manufacturing conditions and the quality of the drug. Hence, the responsibility to the consumer falls on the bigger concept of drug regulation.
- Publisher
- Academic Press
- Keywords
- Drug regulation; Drug safety; Financial resources; Governance; Legislative tools; Medical devices; National regulatory authorities; Quality control
- Department(s)
- Surgical Oncology
- Publisher's Version
- https://doi.org/10.1016/B978-0-323-90186-4.00060-2
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2025-04-24 05:44:21
Last Modified: 2025-04-24 05:45:33