Joshua Sharlin, PhD Expert Witness
Curriculum Vitae

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Specialties & Experience

General Specialties: Medical Devices and Pharmaceutical Regulation

Specialty Focus: FDA, FDA Compliance, FDA Regulations, FDA Software, FDA Drug Safety, FDA Warnings, FDA Drug Warnings FDA Medical Device Safety, Hip Implant Safety/FDA, Medical Device Safety/FDA, Drug Safety/FDA, Labels/FDA, Biologics Safety FDA, Implant Safety/FDA, 510(k)/FDA, NDA/FDA, IND/FDA

Education: BS, University of Iowa; MS, University of Maryland; PhD, University of Georgia

Years in Practice: 25

Number of Times Deposed/Testified in Last 4 Yrs: 8


Additional Information

Have provided Food and Drug Administration (FDA)-related regulatory support to attorneys in cases involving; (i) death or injury caused by drugs, biologics or medical devices, (ii) patents, (iii) insurance claims, (iv) wrongful termination, (v) trade secrets, (vi) merger and acquisitions. Expert in data integrity and software development. Talented in testimony and depositions. Hands-on experience in the entire lifecycle of FDA-regulated product development, from developing an initial regulatory strategy, thru data collection and analysis, to review and approval at FDA. Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it? (See page 3 for a description of expert witness projects.)