Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Ministry of Health and Family Welfare, Government of India has issued the Medical Devices
The Government of India has published a draft notification proposing an amendment to the Drugs
Biosimilarity CAA more sensitive than CES The USFDA has published a draft guidance updating scientific
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The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence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
