Warning letters, 483s, Recalls, Import Alerts, Audit observations
Government of India is amending the New Drugs and Clinical Trials (NDCT) Rules 2019 permitting
Government of India has published the Gazette notification to make disclosure of Qualitative details of
The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence
USFDA has allowed drug manufacturers additional time for submission of mitigation actions and required changes
USFDA has issued the final guidance for Pre-Submission Facility Correspondence (PFC) for prioritised generic drug
Indian regulatory agency, CDSCO has updated the requirements for application and issuance of Export NOC
The Drugs Technical Advisory Board (DTAB) in India has recommended for amendment of Drug Rules
WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in
Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs
Health Ministry in India has extended the timeline for implementation of the revised Schedule M
