Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

USFDA Warning Letter to Akron Formulatio

The USFDA has issued a Warning Letter to Hyderabad-based OTC manufacturer Akron Formulations for critical

CDSCO Flags Spurious and Poor Quality Dr

The Indian drug regulator, CDSCO, has published a list of spurious drugs detected in November

One More Drug Recall for NDSRI From Glen

Adding to the growing number of drug recalls due to NDSRIs in 2024, Glenmark is

USPTO Withdraws Proposed Rule Targeting

The USPTO is withdrawing the proposed new rule which was published in the Federal Register

FDA Approves New Skin Cancer Drug

USFDA has approved Checkpoint Therapeutics Cosibelimab-ipdl (Unloxcyt) for treatment of skin cancer CSCC (metastatic cutaneous squamous

FDA Approves New Drug for Control of And

The USFDA has approved Neurocrine Biosciences’ new drug, Crenessity (Crinecerfont), for the treatment of classic

Major Recall of Aurobindo’s Anti-Depre

Several lots of the antidepressant drug Duloxetine, manufactured by Aurobindo, India, have been recalled in

CDSCO Issues Spurious Drug Alert for Pop

The Central Drugs Standard Control Organization (CDSCO) has issued a spurious drug alert for popular

EC General Court Refuses to Extend Suspe

In September 2024, the European Commission (EC) revoked the Conditional Marketing Authorisation (CMA) for Advanz

USFDA Flags Major cGMP Deviations at Une

New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch