Catherine E Patterson, PhD
Biotech Research Group (BRG)
Warnings & Labels Expert Witness, Pharmaceutical Regulation Expert Witness
Pharmaceutical, Drug, Device, Failure to Warn, Labeling, FDA, Regulatory, Product Liability, OTC, Prescription, Safety, Risk
Dr. Patterson has focused on human disease and treatments with attention to both efficacy and safety. Investigations of medical literature, legal files and regulatory documents for medical conditions, drug products and medical devices as well as comparators are the basis of her regulatory opinions. Any pharmacovigilance, device safety reviews, adverse event and labeling analyses use resources such as PubMED, Embase, FAERS, MAUDE, and internal company documents. Her regulatory experience has included 510(k), PMA, pre-IND, IND, NDA, ANDA and 505(b)(2) submissions.
Dr. Patterson routinely writes FDA submissions, white papers, clinical study protocols, medical descriptions and labeling. She has additional experience with peer-review publications and grant writing. She is currently the Chief Scientific Officer for Biotech Research Group in Tampa.
Her PhD was awarded from Princeton University in Molecular Biology for her work with viruses. In the past she provided scientific re...
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