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A newly released Form 483 faults Indian drugmaker Glenmark Pharmaceuticals for neglecting multiple controls in its procedures at its Pithampur facility. Read More
Oeyama-Moto is back in the hot seat after the agency accused the company of violating a clinical hold the agency had placed on a clinical trial. Read More
The FDA is accusing two companies — one a dietary supplement manufacturer and one an API maker — of committing a multitude of GMP violations. Read More
Companies developing direct-acting antiviral hepatitis C drugs should factor in interferon treatment when designing clinical trials, the FDA said Tuesday. Read More