CDRH Postmarket Surveillance Final Rule To Take Effect July 8
This article was originally published in The Gray Sheet
FDA approval need only be obtained for "significant" changes to approved postmarket surveillance (PS) studies, the agency clarifies in a 1June 6 final rule
You may also be interested in...
Medical device manufacturers would be able to satisfy postmarket surveillance orders using secondary data collection methods or literature reviews, provided their proposed method answered the surveillance question posed by FDA, under an Aug. 29 proposed rule.
The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.
Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.