Pharmacovigilance
The Importance of Patients Perspectives: Patient Reported Outcome Measures
The Importance of Patients Perspectives: Patient Reported Outcome Measures
What are late-phase clinical studies and why are they important?
Late-stage clinical studies are postmarketing trials classified as Phase IIIb and Phase IV that are conducted to establish a drug’s long-term safety and efficacy following regulatory approval, and to provide product differentiation and positioning in the competitive drug [...]
Important Considerations in Clinical Research and Pharmacovigilance
Important Considerations in Clinical Research and Pharmacovigilance
With an overall goal in protecting public health, the objective of pharmacovigilance (PV) is to promote the safe clinical use of medicines and prevent adverse drug reactions from clinical investigation throughout post-marketing of a drug. While there are multitudes of factors that affect a PV program, the focus of [...]
FDA Patient Safety News- Advice for Patients: Warning on Swallowing Benadryl Topical Gel July 1, 2010
- Recalls and Safety Alerts: Warning on Liver Injury with Propylthiouracil July 1, 2010
- Recalls and Safety Alerts: Using External Infusion Pumps Safely July 1, 2010
- Recalls and Safety Alerts: Medication Guide Required for Vivitrol July 1, 2010
- New Medical Products: New Cellular Immunotherapy for Advanced Prostate Cancer July 1, 2010
