Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA approves Sage Therapeutics Zurzuvae

Zurzuvae (zuranolone), the first oral medication to treat postpartum depression (PPD) in adults. PPD is a

FDA published the fiscal year FY 2024 GD

The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293.

Four Indian Pharma sites issued Warning

Related Links Warning letter Intas Warning letter Centaur Warning letter Medgel Warning letter Baxter Intas

Warning letter to Intas, Ahmedabad after

Intas facility at Matoda, Sanand in India (FEI 3004011473) was inspected by FDA investigators Jose E

Lupin recalls 4179 boxes of Drospirenone

Lupin recalls 4179 boxes of Tydemy. Tydemy is Drospirenone, Ethinyl Estradiol & Levomefolate Calcium Tablets

Lupin announces resolution of Warning le

Lupin has received correspondence from the US FDA that Lupin has addressed the concerns raised

FDA Approves Tarsus’s Lotilaner (XDEMV

Tarsus Pharmaceuticals Inc., in a statement announced FDA approval of Lotilaner ophthalmology solution 0.25% (XDEMVYâ„¢).

FDA Approves YCANTH For Treatment of Mol

Verrica Pharmaceuticals Inc. is a dermatology therapeutics company developing medications for skin diseases requiring medical

EMA Updates Nitrosamines Q&A documen

EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits

Centaur Warning letter : Data Integrity,

Centaur Pharmaceuticals, India issued Warning letter by USFDA. The Warning letter dated 5 June 2023