Device Center Extramural PMA Review Contracting Supported By Feigal
This article was originally published in The Gray Sheet
FDA should allow manufacturers to pay "outside experts" to review all or part of their premarket approval applications, according to a proposal being advanced by device industry groups
You may also be interested in...
While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.