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Video on Methodology

by Dr. Joshua Sharlin, Ph.D. | Jan 29, 2025 | FDA Expert Witness, Videos

Sharlin Consulting, LLCJoshua Sharlin, Ph.D....

Video Skills & Experience

by Dr. Joshua Sharlin, Ph.D. | Jan 29, 2025 | FDA Expert Witness, Videos

Sharlin Consulting, LLCJoshua Sharlin, Ph.D. Skills and...

What Needs to be in an FDA Product Submission: A Reviewer’s Perspective

by Dr. Joshua Sharlin, Ph.D. | Dec 9, 2020 | FDA Expert Witness, What Needs to be in an FDA Product Submission: A Reviewer’s Perspective

Download this content as a slide deck 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...

FDA and DEA Litigation Briefing

by Dr. Joshua Sharlin, Ph.D. | 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...

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