Proposed establishment of the "Regulation on Standards for Excellent Management System Certification"; (39 page(s), in Korean)

Notice of Proposed Rulemaking and Announcement of Public Hearing: Amendments to Article 6, Clear and Reasonable Warnings Safe Harbor Methods and Content; (9 page(s), in English)

FDA Circular No. ____ Subject: Guidelines on the Classification of Deficiencies Observed During Inspection of the Conduct of Clinical Trials; (4 page(s), in English)