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A Form 483 describes the quality problems that led the FDA to ban imports from Ranbaxy’s Toansa, India plant, with investigators troubled by workers retesting samples until they get acceptable results. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
An FDA task force last month recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history. Read More
The European Medicines Agency is urging healthcare providers to inspect vials of the cancer drug Herceptin for signs of tampering following reports that some vials of the drug were stolen in Italy, tampered with and reintroduced into the supply chain. Read More
Although great strides have been made by Chinese officials to improve the quality of drugs made in the country, more needs to be done, according to U.S. regulators and drug safety advocates. Read More
Manufacturers estimate that a medium-sized drugmaker would have to pay roughly $36 million to implement a serialization and traceability system required under the new federal track-and-trace law. Read More
Indian generics maker Sun Pharmaceutical said last week that it will close its Detroit, Mich., plant this summer as part of its consolidation of U.S. manufacturing operations. Read More
House lawmakers are seeking new ways to streamline the drug development and approval process, calling for solutions to reverse high costs of clinical trials and the slow supplemental application pathway. Read More
AstraZeneca (AZ) rebuffed a new $106 billion merger bid from Pfizer on Friday, saying that even after Pfizer added $6 billion to the offer it still “substantially” undervalues the company. Read More
The pharmaceutical industry is worried the FDA will hinder the distribution of valid scientific information on off-label drug uses in its new proposal detailing what literature sales reps can distribute to physicians. Read More