Chart: FDA’s Warning Letters Released the Weeks of Nov. 12, 19 & 26
This article was originally published in The Gray Sheet
FDA's Warning Letters Released the Weeks of Nov. 12, 19 & 26
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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.
Approved in February as an on-demand remedy, Nurtec will be filed for migraine prevention after success in Phase III. It could be the first oral preventive therapy and first dual purpose migraine drug.
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.