Joshua Sharlin, PhD

STEVENSVILLE, Maryland
Joshua Sharlin, PhD Expert Witness
Curriculum Vitae

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Specialties & Experience of this Expert Witness

General Specialties:

Pharmaceutical Regulation and Medical Devices

Keywords/Search Terms:

FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability

Education:

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

Years in Practice:

30

Number of Times Deposed/Testified in Last 4 Yrs:

16

Additional Information

Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times. Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries. Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions. 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? Provide FDA related regulatory support to attorneys in cases involving; (i) death or injury caused by drugs, biologics, or medical devices, (ii) patent infringement, (iii) insurance claims, (iv) wrongful termination, (v) trade secrets, (vi) merger and acquisitions, (vii) stock fraud, (viii) software development, (ix) data integrity.