The inadequacies of pre‐market chemical risk assessment's toxicity studies—the implications
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Applied Toxicology"
DOI: 10.1002/jat.3396
Abstract: Industry provides essentially all the data for most (pre‐market) chemical risk assessments (RA); academics study a chemical once it is marketed. For two randomly‐chosen high production chemicals, despite new European Union mandates to evaluate all… read more here.
Keywords: chemical risk; market; pre market; market chemical ... See more keywords
Evolution of China regulatory guidance on the clinical evaluation of medical devices and its implication on pre-market and post-approval clinical evaluation strategies
Sign Up to like & getrecommendations! Published in 2023 at "Expert Review of Medical Devices"
DOI: 10.1080/17434440.2023.2184258
Abstract: ABSTRACT Introduction The rapid growth of the medical device industry has driven the evolution of regulatory guidance on medical device clinical evaluation (MDCE) of the China National Medical Products Administration (NMPA), which consequently influences pre–market… read more here.
Keywords: pre market; clinical evaluation; post; guidance ... See more keywords
Catch-22: ADM and FDA Pre-Market Approval: How Can We Construct Studies?
Sign Up to like & getrecommendations! Published in 2022 at "Plastic and reconstructive surgery"
DOI: 10.1097/prs.0000000000009701
Abstract: As a biologic product derived from human tissue, acellular dermal matrices (ADMs) did not require pre-market approval for their initial use as a soft tissue support product. Since their first utilization in breast surgery, ADMs… read more here.
Keywords: market approval; surgery; breast; pre market ... See more keywords