Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA approves Akebia’s Vafseo (Vadadust

FDA approved Akebia’s Vafseo (Vadadustat) for treatment of anaemia due to Chronic Kidney Disease (CKD)

FDA approves Merck’s Winrevair (Sotate

FDA has approved Merck’s Biologic drug Winrevair (Sotatercept-CSRK) for Pulmonary Arterial Hypertension (PAH). The product

Eugia US LLC Recall one more Drug in US

Eugia US LLC is recalling one lot of Methocarbamol Injection in US for white particles

FDA Issues guidance for Handling and Ret

FDA has issued a new guidance for handling reserve samples from bioavailability (BA) and bioequivalence

USFDA Approves Duvyzat for Muscular Dyst

USFDA has approved Italfarmaco’s Duvyzat (givinostat) oral medication for treatment of Duchenne Muscular Dystrophy (DMD).

USFDA approves Idorsia’s Tryvio (Aproc

USFDA has approved Idorsia’s new drug Tryvio, a New Molecular Entity (NME) drug Aprocitentan for

EMA Updates list of N-Nitrosamines

EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15

USFDA flags made in China plastic syring

USFDA has updated Safety Communication on Chinese made plastic syringes. FDA had issued a Safety

USFDA 483 to Eugia Polepally unit cites

USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in

USFDA issues guidance for Animal Drug Ap

USFDA has issued a new guidance for primary batches to be included in the CMC