Drug approval is the goal of the long process of drug development. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority ...
Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "eCTD Submissions - Fundamentals and Process" training has been added to ResearchAndMarkets.com's offering. eCTD Submissions, or electronic Common ...
Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course" training has been added to ...
The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the scholarly analysis of legislation, regulations, court decisions, and public policies affecting the development, manufacture, ...