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The FDA rejected Spectrum Pharmaceuticals’ Qapzola, a treatment for non-muscle invasive bladder cancer, the company said following receipt of a CRL. Read More
The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More
Nicox, an international ophthalmic R&D company, announced it received a complete response letter related to its NDA for its cetirizine eye drop formulation AC-170. Read More
Syntese has received a Form 483 after an inspection revealed sanitation, quality and laboratory control issues at the Denmark-based API maker. Read More
UK-based Wallace Cameron International has not fulfilled its registration obligations to continue manufacturing and exporting drugs to the United States, the FDA said. Read More
A pharmaceutical company in Beijing has received a warning letter from the FDA after barring investigators from the facility as well as falsifying and back-dating records. Read More
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. Read More