Drug Labels Expert Witnesses
Drug labels 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 drug labels. The drug labels expert witness listings on this page are typically from fields/areas of expertise such as: Infectious Diseases and Pharmaceutical Research.
Peter Coderre, PhD Antimicrobial Regulatory Consulting
Lovettsville, Virginia
Pharmaceutical Research, Infectious Diseases
-
pharmaceutical regulation, FDA, drug development , antimicrobials , antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, microbiology , virology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro
25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science.
Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense.
Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs.
As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...
