The Hindu·2 min read·medium
Clinical investigator associated with study at Alembic’s bioequivalence unit gets U.S. FDA warning letter
T
The Hindu Bureau
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Alembic Pharmaceuticals announced that the U.S. FDA issued a warning letter to a clinical investigator involved in a bioequivalence study at their Vadodara facility. The company stated the issue relates to informed consent documentation rather than data integrity.
Alembic Pharmaceuticals on Monday said the U.S. Food and Drug Administration (U.S. FDA) has issued a warning letter to the clinical Investigator associated with a bioequivalence study conducted at the company’s bioequivalence facility in Vadodara.
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