FDA Safe Use Initiative Targets NSAIDs, Pediatric Dosing, Drug-Impaired Driving
This article was originally published in The Tan Sheet
Executive Summary
CDER touts its Safe Use Initiative as addressing OTC and Rx mis-use and reducing risks to consumers by partnering with industry stakeholders and health care professionals. CDER Professional Affairs and Stakeholder Engagement Director John Whyte says he wants to “build capacity” behind the program.
You may also be interested in...
Draft Guidance Drills Down With Details To Cut Pediatric Acetaminophen Overdose Risk
FDA suggests new and repeats previous recommendations to reduce the risk of pediatric overdose with acetaminophen products due either to unsupervised ingestion or therapeutic errors. The guidance includes greater detail on delivery devices and labeling information for pediatric acetaminophen OTCs.
CDER Outreach Coordinator’s First Task Is Safe Use Initiative
John Whyte joins FDA from Discovery Channel to be director of professional affairs and stakeholder engagement.
Cosmetics Industry Awaits FDA’s Allergen List While Working To Inform GMP Rulemaking
The Independent Beauty Association does not yet have insight into what ingredients will be listed in the US FDA’s proposed rulemaking for cosmetic allergen labeling – due by 29 June – but is optimistic the agency will consult industry when it comes to setting the compliance timeline. Meanwhile, industry stakeholders are pushing for international harmonization in the agency’s cosmetic GMPs rulemaking.