“FDA has not yet developed action plans to fully address travel, workload, and work-life balance because potential solutions ...

Mumbai: Cipla has announced that the United States Food and Drugs Administration (USFDA) has concluded an inspection at the ...

Cipla Ltd on Wednesday (November 13) announced that the US Food and Drug Administration (US FDA) has issued ... Bengaluru.

A key reason positions haven't been filled is that they require travel that ranges from 25% to 75% of the time.

The GAO report highlights FDA's drug inspection program challenges, including 36% fewer inspections in 2023 compared to 2019 ...

Abbott's Freestyle Libre 2 and 3 are the first CGMs to receive FDA clearance for use during imaging tests like X-rays, CT scans, and MRIs.

The FDA conducted an inspection at the manufacturing facility in Virgonagar from Nov. 7 to Nov. 13, according to an exchange ...

The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.

In July 2024, Checkpoint announced that the FDA accepted for review the resubmission of its BLA for cosibelimab as a complete response to the complete response letter (“CRL”) issued in December 2023 ...

the adequacy of the responses to the inspection issues submitted to FDA by our third-party CMO, our projections of regulatory review timelines, the commercial potential of cosibelimab, if approved, ...

HYDERABAD: Pharma player Granules India Limited on Friday said it has received an Establishment Inspection Report (EIR) from ...