Distributor use of MDR form 3500A encouraged but not required, FDA says in draft CPG.
This article was originally published in The Gray Sheet
DISTRIBUTOR USE OF MEDWATCH FORM 3500A ENCOURAGED BUT NOT REQUIRED, FDA says in an Aug. 28 draft compliance policy guide. "Although the 3500A reporting form is not currently required for distributors, the FDA encourages distributors to use this form," the agency says, noting that this would "reduce the paperwork and level of effort" for distributors, manufacturers and FDA.
You may also be interested in...
Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.
Managing partner Corey Goodman said venBio didn’t have trouble closing its fund, because the venture capital firm prepared its investors for an economic downturn months ago.
The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.