Greg Salimando
Staff Regulatory Fellow at the Center for Biologics Evaluation and Review (CBER), Office of Therapeutic Products (OTP)
- Role
- Staff Fellow at FDA
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Greg Salimando
I am Neuroscience PhD and current Regulatory Staff Fellow in the Office of Therapeutic…
Experience
Staff Fellow
Dec 2024 — Present · Silver Spring, MD, US
Reviews and provides scientific and regulatory guidance on pharmacology and toxicology studies for cellular products, gene therapy products, hemostatic products, selected plasma derivatives, and/or tissue-engineered products. •Reviews preclinical studies and scientific literature, as well as toxicological and pharmacological data submitted to CBER/OTP for advanced therapy products under review. •Prepares comprehensive summaries of data and participates in the development of preclinical and clinical guidance’s and procedures for advanced therapy products under review in OTP submitted in an IND/IDE or BLA.
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