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Expert Bio

Primary Area of Expertise

FDA Regulatory Affairs

Expert Witness Profile

Dr. Sharlin, a former FDA reviewer, assists attorneys in cases involving; death or injury caused by drugs/biologics/medical devices, also patents, insurance claims, trade secrets, product labeling, and mergers and acquisitions. He is skillful at writing expert reports, being deposed and giving testimony regarding regulatory and compliance-related issues including failure to warn, the FDA approval process, labeling, expressed warranty, negligent manufacturing, complaint handling, and safety reporting. His credentials in data integrity and software development were perfected while working as Director of Hotel Customer Information Systems for Marriott International. Over 50,000 people have attended his training classes on over 40 FDA- related topics.