National Reye's Syndrome Foundation
Executive Summary
Requests that FDA-mandated labeling for products containing aspirin be extended to all salicylate-containing products. "Too many cases of Reye's Syndrome have suspiciously been linked to one product in particular, [Procter & Gamble's] Pepto-Bismol, to account for it being coincidental," Chicago Chapter President Carolyn Jender maintained in a recent letter to FDA. The foundation believes that 20%-25% of Reye's Syndrome reported cases are the result of salicylate-containing products.
You may also be interested in...
Roche/Genentech Keeps Commitment To External Cancer Innovation
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
Unprecedented To Lawful: Regulatory Precedent Needed For Cannabinoids’ Use In Supplements?
“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: