Fda Drug Safety Expert Witnesses
Fda drug safety expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on fda drug safety. The fda drug safety expert witness listings on this page are typically from fields/areas of expertise such as: Medical Devices and Pharmaceutical Regulation.
Joshua Sharlin, PhD SHARLIN CONSULTING
STEVENSVILLE, Maryland
Pharmaceutical Regulation, Medical Devices
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FDA,
FDA expert
FDA Compliance,
FDA Regulations,
FDA MAUDE ,
FDA Drug Safety,
FDA Warnings,
FDA Drug Warnings
FDA Medical Device expert,
FDA law,
FDA regulatory,
Drug Safety/FDA,
FDA Medical Devices,
Biologics Safety FDA,
Implant Safety/FDA,
Medical device product liability
Dr. Sharlin’s experience:
My key skill is identifying and developing facts supporting a legal strategy.
(1) Drug reviewer at FDA.
(2) Expert witness experience: Cases-37, Expert reports-16, Depositions-8,
Testimony-1, Successful Daubert challenges-0.
(3) Professional experience: Regulatory consultant (25 years), expert witness (10 years).
(4) My cases have involved drug and medical device death and injury, patents, mergers, trade secrets, business interruption insurance, product labeling.
(5) My skills: biological scientist, statistician, software developer, data integrity specialist, technical writer, educator, and FDA regulatory expert.
(6) Talented technical writer, my writing experience includes:
Expert reports, scientific publications, audit reports for FDA compliance, standard operating procedures, FDA submissions, responses to questions from FDA.
(7) I write custom software for data mining of safety information from FDA’s adverse event databases:
I extract f...
