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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
The FDA is looking to shed light on the sometimes murky rules governing compounding operations to distinguish heavily regulated outsourcing facilities from tiny compounding operations that are lightly regulated. Read More
The list of Chinese pharmaceutical companies in the FDA’s crosshairs keeps on growing, with the agency hitting two drugmakers for GMP violations and another for refusing an inspection. Read More