Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA Issues Warning Letter to Zydus: Fl

Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,

FDA Announces FY 25 GDUFA Rates, ANDA Fe

The USFDA has announced the fiscal year (FY) 2025 rates for GDUFA III fees. The

FDA Final Guidance: Delaying, Denying, L

FDA has issued final guidance on Circumstances that constitute Delaying, Denying, Limiting, or Refusing a

FDA issues Guidance on Facility Readines

The guidance provides information on how FDA decides goal dates for a drug application (ANDA,

FDA announces OTC Drug Facilities fee fo

FDA has announced the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC

USFDA flags made in China plastic syring

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

Chinese API Mfr Sichuan Deebio issued Wa

USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI

USFDA and EMA Parallel Scientific Advice

Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD

FDA issues final guidance for annual rep

Each Drug Establishments (Registrants*) registered with FDA must provide information on amount of each listed

FDA announces opportunity for drug manuf

The USFDA announced next phase of the Quality Management Maturity (QMM) Program for drug manufacturers.