A detailed description of FDA requirements for financial disclosure by clinical investigators. The content includes; 1) Five key definitions, 2) Five significant penalties for noncompliance, 3) Dollar thresholds that trigger reporting requirements…. read more

An insightful presentation that explains how FDA reviewers examine a submission.It includes 3 practical ideas for how to create a better submission. These ideas apply to submissions for drugs, biologics, and medical devices. Over 1,000 companies have paid to… read more