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Full-Text Articles in Law
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Catholic University Law Review
The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the …
Regulation Of Research With Children: The Evolution From Exclusion To Inclusion, Duane Alexander
Regulation Of Research With Children: The Evolution From Exclusion To Inclusion, Duane Alexander
Journal of Health Care Law and Policy
No abstract provided.
(Women And) Children First: Applicable To Lifeboats? Applicable To Human Experimentation?, Lainie Friedman Ross, M. Justin Coffey
(Women And) Children First: Applicable To Lifeboats? Applicable To Human Experimentation?, Lainie Friedman Ross, M. Justin Coffey
Journal of Health Care Law and Policy
No abstract provided.
Pediatric Priorities: Legislative And Regulatory Initiatives To Expand Research On The Use Of Medicines In Pediatric Patients, Michael S. Labson
Pediatric Priorities: Legislative And Regulatory Initiatives To Expand Research On The Use Of Medicines In Pediatric Patients, Michael S. Labson
Journal of Health Care Law and Policy
No abstract provided.