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With only 14 compounding facilities having volunteered for FDA oversight in two months, the agency is now asking hospitals and state authorities to get behind the registration effort. Read More
The International Society of Pharmaceutical Engineering (ISPE) is recommending six quality metrics that the FDA should consider collecting from manufacturers as part of the agency’s new quality metrics program. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More
Ranbaxy’s regulatory woes deepened Jan. 23 as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More
Japan’s national drug regulator has asked drugmakers to submit information on stability monitoring and water purity, in addition to existing requirements, when they apply for mandatory post-approval GMP inspections. Read More
The FDA has hit two compounding pharmacies with warning letters for quality violations and failure to have prescriptions for products they were compounding. Read More
Japan’s national drug regulator has asked drugmakers to submit information on stability monitoring and water purity, in addition to existing requirements, when they apply for mandatory post-approval GMP inspections. Read More
Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More