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- FDA issues warning letters to Indian OTC drugmaker for falsified logbooks and to two others for GMP testing lapsesThe U.S. Food and Drug Administration sent a warning letter to an over‑the‑counter drugmaker in India after discovering that the company had submitted falsified logbooks to the agency. In addition…
- Early regulatory operations planning key to submission-ready dossiersRegulatory operations are often treated as a final step after all scientific data are compiled, but the article argues they should be integrated from the start of a development program. A dossier…