Requests for journal articles on off-label uses can be filled by device firms -- FDA.
This article was originally published in The Gray Sheet
JOURNAL ARTICLES ON OFF-LABEL DEVICE USES: UNSOLICITED REQUESTS for the articles can be filled by manufacturers as long as they document the activity, Byron Tart, head of the promotion and advertising policy staff in the device center's Office of Compliance, told attendees at a Food and Drug Law Institute conference Sept. 7 in Washington, D.C. FDA's Center for Devices and Radiological Health plans to send a letter to manufacturers in the next few months informing them of the policy change.
You may also be interested in...
Purell Battling Class Actions Over Disease Claims While World Scrambles To Increase Hand Sanitizer Supplies
Leading chemical firms, beauty and consumer health companies, even distilleries and medical marijuana cultivators are adapting operations to meet global demand for hand sanitizers amid the COVID-19 pandemic. Meanwhile, plaintiff’s attorneys are busy with multiple class actions against Purell manufacturer GOJO Industries for alleged false advertising following a January warning letter to the firm from the US FDA.
FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments
Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs.
FDA Commissioner Stephen Hahn was added to the White House's pandemic task force as the outbreak grew, but he remained in a background role. That all changed the morning of 18 March, when President Trump tweeted: “I will be having a news conference today to discuss very important news from the FDA concerning the Chinese Virus!” A day later, Hahn was standing with Trump at the podium for the now-daily press briefings on Covid-19.