Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

CDSCO Drug Alert: Assay, Dissolution Fai

In December 2024, the Indian drug regulator, CDSCO, flagged 51 drugs as Not of Standard

CDSCO Flags Spurious and Poor Quality Dr

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

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

Oral Phenylephrine Not Effective: FDA Pr

USFDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) drug

Spurious Drugs Linked to Sun Pharma, Gle

CDSCO has published an update on the Spurious and Misbranded drugs in September 2024. Medicinal

CDSCO Drug Alert for August 24

CDSCO has published alert of list of drugs Not of Standard Quality (NSQ) identified during

Ocaliva: EC Withdrawal of Approval Tempo

The European Commission (EC) revoked the conditional marketing authorization (CMA) of Advanz Pharma’s Ocaliva (obeticholic

CDSCO Alert: Baxter Recalls Fibrin Seala

CDSCO has published a drug alert regarding voluntary recall of Tisseel Lyo Fibrin Sealant VHS/D

CDSCO NSQ Drug list: Failure for Dissolu

CDSCO has published the NSQ (Not of Standard Quality) alert for July 2024. The list