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- Title
Guidance on risk management.
- Abstract
The US Food and Drug Administration (FDA) has announced the availability of three draft guidances to help industry develop risk management activities when needed for some drugs and biological products. The draft guidances describe additional safety testing, monitoring, and interventions that may be helpful in selected circumstances and address premarket risk assessment; the development, implementation, and evaluation of risk minimization action plans. For example, the draft guidance on premarket risk assessment focuses on measures sponsors might consider during the later stages of clinical development of products that are known to, or might, present special safety issues.
- Subjects
UNITED States; DRUGS; CLINICS; MATERIA medica; HEALTH facilities; RISK management in business; INSURANCE
- Publication
WHO Drug Information, 2004, Vol 18, Issue 2, p153
- ISSN
1010-9609
- Publication type
Article