3 Fda Medical Product Regulation Expert Witnesses Found

Plastic Surgery, Wound Care - Breast and Body Contouring, Aesthetic and Reconstructive Wound Management, Wound Care

...He has participated in several investigations for government regulators serving as a principle investigator for the FDA in multiple clinical studies regarding medical implant devices. Additionally, he has performed investigative work for private corporations gaining vast knowledge of the products and procedures used in many fields of medicine and surgery. Dr. Baker earned his Bachelor’s degree in pre-medicine in 1973 from Auburn University and received his Medical Degree in 1977 from the University of South Alabama College of Medicine in Mobile, AL. He completed his 5-year internship and residency in General and Vascular Surgery at Carraway Methodist Medical Center in Birmingham, AL in 1982. After 9 years of General Surgery practice, Dr. Baker completed a residency in Plastic & Reconstructive Surgery at the Mayo Clinic in Rochester, MN. He began his practice of Plastic and Reconstructive Surgery in Dothan, AL in July, 1993 retiring from the operating room in 2020. Dr....

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 holds a medical degree from New York University School of Medicine, and an undergraduate degree in Molecular Biophysics and Biochemistry from Yale University. He completed his internal medicine residency training at NYU Medical Center, and infectious disease fellowship training at Yale University. Dr. Ross also holds a M.S. and Ph.D. in Biochemistry from NYU, and a Master’s Degree in Biomedical Informatics from Oregon Health and Sciences University. Dr. 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....

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?...