FDA Asks Narcolepsy Patients How Symptoms Change Over Time
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency plans a half-day meeting Sept. 24 on narcolepsy symptom burden and current treatment options, part of its patient-focused drug development initiative under PDUFA V.
You may also be interested in...
FDA Sees Challenge In Distinguishing Lung Cancer Symptoms From Drug Side Effects
At the third patient-focused drug development meeting under PDUFA V, FDA staff urged patients to try to differentiate between symptoms caused by the underlying disease and those resulting from treatment, an important distinction when it comes to assessing the efficacy and safety of new drugs.
Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials
Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.
Two Years In US Accelerated Approval Withdrawals
Twenty accelerated approval indications have been voluntarily withdrawn by sponsors since December 2020, most coming as a result of the FDA cancer office’s push to rid labeling of ‘dangling’ and ‘delinquent’ indications that lack confirmation of clinical benefit.