McCaskill Not Sold On Retailer Exemption From Supplement AER Filing
This article was originally published in The Tan Sheet
Executive Summary
FDA regulations exempt retailers from compiling supplement adverse event reports, even for products that bear a store brand. Private label firms or contract manufacturers are required to receive AERs linked to those products and to forward reports of serious events to FDA within 15 days.
You may also be interested in...
FDA Needs To Track Actions Built On Supplement AERs – GAO Report
A GAO report says FDA “may be able to expand” its use of supplement adverse event reports if it can track its use of the data to support actions it takes to protect consumers. The report makes five key recommendations for the agency to improve its approach to AERs.
Final AER Guidance Requires Full Address, Recommends Prefatory Language
In its final adverse event reports labeling guidance documents released Sept. 1, FDA does not budge on defining "domestic address" as a full mailing address, or on recommending labels include statements directing consumers how to submit AERs
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.