Adverse Events, Direct From The Consumer
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's proposed consumer version of the MedWatch form for reporting drug-related adverse events goes before an advisory panel.
You may also be interested in...
Lies, Damn Lies, And DTC Ads?
FDA's Risk Communications Advisory Committee is set to discuss how quantitative risk information can be presented in such a way as to inform rather than mislead consumers.
Sentinel Initiative Needs Better Defined Goals, Outside Review Concludes
The Pharmacovigilance Review Subcommittee of FDA's Science Board reports a lack of clarity within CDER over just what purpose the drug safety program is supposed to serve.
Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.