6 Fda Expert Fda Compliance Expert Witnesses Found

Medical Devices, Biomedical Engineering - FDA, Medical Devices, FDA Compliance, FDA law, FDA Inspections, FDA medical device regulation, FDA medical device labeling, FDA regulation of clinical trials, FDA approval of medical devices. Medical Device Recalls, Medical Device Complaints, FDA Inspections

A recognized expert on the FDA regulation of Medical Devices. Experience as an expert witness involving medical device firms and FDA requirements regarding approvals, recalls, complaint investigations, and labeling. Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular device. Serve as an expert witness for cases involving FDA regulation compliance for medical devices. Regularly perform webinars regarding FDA and issues regarding clinical studies and medical devices....

Pharmaceutical Regulation, Infectious Diseases - Food and Drug Administration (FDA), drug/biologics safety/labeling/post-marketing surveillance, FDA drug/biologics regulations/procedures/applications (INDs/NDAs/BLAs), clinical trials, drug development, pharmacy compounding, HIV, MRSA, antibiotics, hepatitis, osteomyelitis, influenza, C. difficile

...Ross spent 10 years with the FDA’s Center of Drug Evaluation and Review (CDER) as a medical officer, senior medical reviewer, medical team leader, and new drug review office management official. He has extremely broad experience with FDA regulatory submissions (INDs, NDAs, BLAs, post-marketing safety, labeling supplements) for both small molecules and biologics. He has extensive familiarity with FDA regulations, processes, and procedures, including drug/biologic labeling and compliance requirements. Dr. Ross was the recipient of CDER’s Excellence in Communication and Excellence in Leadership Awards. Dr. Ross has published extensively in book chapters and medical articles. He is a frequently invited presenter at medical conferences, industry meetings, medical societies, and hospital grand rounds. Dr. Ross is an experienced expert witness at the federal and state levels. Dr....

Pharmaceutical Regulation, Medical Devices - FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability

Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times. Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries. Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions. Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it?...

Regenerative Medicine - cell therapy, gene therapy, stem cell therapy, immunotherapy, regulatory, FDA, due diligence, HCT/P, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), viral vectors, T cells, CAR-T cells, NK cells, stem cells, autologous cell therapy, allogeneic cell therapy

...Burger has been an expert witness in cases involving cell and gene therapy intellectual property, commercialization, FDA regulatory affairs, and GMP compliance. He is frequently an invited speaker at international conferences and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis and is author of over 200 scientific publications and presentations, and recipient of numerous honors and awards.

Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use

...Provide leadership in support of label development for new applications, supplemental applications, revision filings based on new clinical data, new safety information, local labeling, new guideline compliance, and agency comments. Responsible for labeling for headquarter Company Core Data Sheet (CCDS), US (USPI), EU (SmPC), Rest of World, and Japan. Develop, lead label development, gain consensus, and shepherd labeling through management review as Chair of Worldwide Product Circular Review/Approval Committees. Tackle >25 products concurrently across the full product life cycle from Target Product Labeling through Phase II, Phase III, and Post Marketing, and in Adverse Experience Reports. Products: Gardasil, RotaTeq, ProQuad, M-M-R II, Varivax, Vaqta, Pneumovax, Recombivax, Isentress, Crixivan, Invanz, Stromectol, Emend, Arcoxia, Cozaar, Hyzaar, Vasotec, Vaseretic, Prinivil, Prinzide, Aggrastat. Cosopt, Trusopt, Timoptic, OTCs....

Pharmacist, Pharmaceutical Regulation - USP <797> <795> <800>, Sterile and non-sterile compounding, FDA 503(a) and (b), State Inspections, Accreditation, Compliance, Critical Point Training, NABP, PCAB, Inspections, FDA Drug Compliance Expert

Kathleen Jackson is a licensed and experienced 40+ year pharmacist with specialized training and experience in compounding and compliance with regulations. She owned and operated a community pharmacy with an emphasis on compounding for 22 years. She has most recently received an NABP Inspector Certification (CISCI) in November 2018, expiring June 2023. Kathleen was also previously accepted by FDA to monitor a pharmacy as a Drug Compliance Expert. She has presented at several PCCA International Seminars as well as local community clubs and organizations. Kathleen was awarded "Pharmacist of the Month" in March 2002 by PCCA (Professional Compounding Centers of America). She has performed inspections and prepared reports to Boards of Pharmacy related to license suspensions/probation orders. Kathleen has co-authored two articles on Root Cause Analysis in the IJPC (International Journal of Pharmaceutical Compounding)....