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The FDA did not buy a manufacturer’s rationale that its quality lapses are due to different Chinese standards, resulting in a warning letter for a slew of violations. Read More
The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. Read More
Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel. Read More
A trade group of small to medium-sized European brand drugmakers has criticized a Spanish government order that may allow biosimilars to be interchanged with their reference product in the same way that generics may be substituted for brands. Read More
A UK healthcare cost watchdog has recommended against national coverage of Dendreon’s novel prostate cancer treatment Provenge, deeming it too expensive. Read More
Six months of additional pediatric exclusivity should be granted only to products that add a children-specific indication, and only if the drug sponsor receives a specific written request from the FDA for studies to support the label expansion, according to the American Academy of Pediatrics. Read More
The FDA late Wednesday approved two breakthrough therapies for idiopathic pulmonary fibrosis: Boehringer Ingelheim’s Ofev and Intermune’s Esbriet, both of which are set to hit the market within the next two weeks, the companies said. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More