Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
CNBCTV18

Alkem Laboratories' arm Enzene Biosciences receives 6 US FDA observations, no data integrity issues

The USFDA completed a Pre-Approval Inspection at Enzene Biosciences, Alkem Laboratories’ subsidiary in Chakan, Pune, on 13th ...
PharmExec

You Can Just (Not) Do Stuff: FDA’s Power to De-Bottleneck Early-Stage Clinical Trials

What’s been overlooked is that the FDA already has the power to fix this. Without new legislation, pilot programs, or years ...
Devdiscourse

USFDA Form 483 Issued to Alkem Laboratories: Six Observations Noted at Chakan Unit

Alkem Laboratories faced a USFDA pre-approval inspection at its Chakan-based facility of Enzene Biosciences, resulting in a ...
NDTV Profit on MSN

Aurobindo Pharma shares fall after USFDA flags severe contamination, data integrity failures

The USFDA further highlighted deficiencies in environmental monitoring in manufacturing areas, indicating gaps in ensuring controlled production conditions.

Aurobindo Pharma clarifies on US FDA inspection reports; stock recovers 3% from day's low

At 11:01 am on Wednesday, shares of Aurobindo Pharma declined 4.44 per cent to Rs 1132, down from its previous close of Rs 1184.65 apiece on the BSE.
Medical Dialogues

Alkem's Enzene Unit Gets 6 USFDA Observations

Alkem Laboratories Limited has announced that the United States Food and Drug Administration (USFDA) has completed a ...