JD Supra

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate for Q-Submissions using eStar

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” ...
https//fedtechmagazine.com

FDA Takes a Big Step Forward With the Electronic Submission Gateway

The Food and Drug Administration’s science-based mission includes receiving, generating and reviewing a wealth of data and products from the vast array of manufacturers and firms that the agency ...
The National Law Review

Spectral AI Announces Submission to FDA of its DeepView® System

DALLAS, June 30, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from ...
Nasdaq

Adial Pharmaceuticals Signs Agreements with Cambrex and Thermo Fisher for AD04 Drug Production and FDA Submission

Adial Pharmaceuticals signs agreements with Cambrex and Thermo Fisher for AD04 drug production and NDA submission for Alcohol Use Disorder. Adial Pharmaceuticals, Inc. has announced the execution of ...