FDA Guidance on Ventilators
Product Profiling and Manufacturing
Endoscopy – Should Everyone Be Tested?
A combined solution to compliance and risk management for sustainability reporting
D T C Advertising
Consumer Health Apps & Mobile Health
Cybersecurity and Data Privacy
TSRGD Roadshow 11 15am robert ringsell [compatibility mode]
FDA 21 CFR Part 11 and Related Regulations and Guidances
Compliance Considerations in Pharmaceutical Product Development Compliance Considerations in Pharmaceutical Product Development John C. (Jack) Garvey,
Using an Independent Statistician to Support a Data Monitoring Committee Patrick D. OMeara, Ph.D. Pat OMeara Associates, Inc. [email protected] FDA/Industry.
1 Revising FDAs Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests FDA/Industry Statistics Workshop September 28-29, 2006.