In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...

Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA ...

In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device ...

Caplin Point Laboratories Ltd.'s share price rose as the US Food and Drug Administration concluded an unexpected inspection ...

The Food and Drug Administration (FDA) will begin collecting samples of raw cow’s milk cheese from across the U.S. to test ...

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1 We have written in the past about companies’ refusal to allow, or make difficult, an FDA investigator’s ability to access certain records or files during an inspection. 2 It is not only a ...

Special Report: Medtech EBR Systems (ASX:EBR) will kick off the new year with a manufacturing pre-approval inspection (PAI) with the US Food and Drug Administration (FDA), which has been scheduled ...

Hyderabad-based US-focused pharma firm Granules India expects the new drug applications from its Gagillapur facility in ...