Joshua Sharlin, PhD
Pharmaceutical Regulation, Medical Devices
FDA MAUDE ,
FDA Drug Safety,
FDA Drug Warnings
FDA Medical Device expert,
FDA Medical Devices,
Biologics 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...