by Josh Sharlin | Dec 9, 2020 | FDA Expert Witness, What Needs to be in an FDA Product Submission: A Reviewer’s Perspective
Download Slides From Presentation 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...
by Josh Sharlin | Jan 11, 2019 | FDA and DEA Litigation Briefing, FDA Expert Witness
Download Article Medical Devices: Individual Liability and MDR ReportingUnited States v. Olympus Medical Systems Corp. and Yabe Plea Agreements, No. 2:18-cr-00727 (D.N.J. filed Dec. 10, 2018) This set of plea agreements initiated from a company’s failure to file...
by Josh Sharlin | Jan 8, 2019 | FDA Regulatory, FDA’s Requirements for Financial Disclosure
Download Slides from Presentation 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...
