Warning letters, 483s, Recalls, Import Alerts, Audit observations
Baxter initiated recall of one lot of Doxil (doxorubicin hydrochloride liposome injection) in U.S due
Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H
In a communique Biocon stated USFDA has categorised inspection classification for Biocon Malaysia as OAI
Velsipity (etrasimod) is an oral, once-daily, 2mg dose medication for adults with moderately to severely
In a company announcement, Biocon informed that it has received a CR (Complete response) letter
In an Interview to CNBCTV18 during visit to India, USFDA Commissioner touched on different topics
The Section 5200.14 of the Manual of Policies and Procedures (MAPP), Filing Review of Abbreviated
Hospira recalled in US one lot of 4.2% Sodium bicarbonate injection and one lot each
USFDA announced it has awarded 10 new clinical trial studies through Orphan Products Grants Program
The electronic platform for processing Prequalification Information of Medicines – ePQs will enable manufacturers, National
