The top documents tagged [draft guidance]

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.