Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Ministry of Health and Family Welfare, Government of India has issued the Medical Devices
The USFDA has released a new draft guidance, Container Closure Systems for Human Drugs and
The USFDA has issued a draft guidance for Establishing Impurity Specifications for Antibiotics in April
The Government of India has published a draft notification proposing an amendment to the Drugs
Imprimis NJOF recalled three intraocular ophthalmic injection drug products in December 2025 (as per USFDA
Biosimilarity CAA more sensitive than CES The USFDA has published a draft guidance updating scientific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The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence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
