JD Supra2d
Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...
Becker's Hospital Review22d
FDA sets meeting on bulk substances: 3 notes
The FDA's Pharmacy Compounding Advisory Committee is set to meet Dec. 4 to address regulatory questions on compounding practices, according to an Oct. 25 news release from the agency. Here are ...
JD Supra1d
FDA Advisory Committee outlines informed consent best practices
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
Yahoo Finance4d
IMNN: Meeting with FDA in Preparation for Phase 3 Ovarian Cancer Trial
As part of the process, the company will be conducting an ‘End-of-Phase 2’ meeting with the FDA later this month to get input from the agency on their proposed trial design. The study is ...
Morningstar18d
NeuroSense Secures Key FDA Meeting to Advance its Phase 3 ALS Trial and NDA Submission
The FDA Type C meeting, scheduled for November 6, 2024, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug. NeuroSense will also ...