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Health Canada has agreed to comply with a Canadian court ruling quashing the agency’s import ban on drugs from a generics manufacturer. In a Nov. 2 statement, Health Canada retracted an information update that prohibited imports from two Apotex manufacturing facilities in India. Read More
The International Society for Pharmaceutical Engineering has launched a drug shortage assessment and prevention tool that helps drugmakers identify risks early on. Read More
In the wake of an avalanche of FDA warnings to Indian drugmakers, Dr. Reddy’s Laboratories is the latest to be hit for GMP deficiencies at three of its Indian sites. Read More
While there is no set timeframe for the release of FDA’s final quality metrics guidance, the agency has plans to recruit volunteers to conduct a “dry run” in the spring to test the collection and sending of data to the agency. Read More
The Federal Court of Canada has quashed Health Canada’s import ban on drugs from two Apotex facilities in India, saying the agency proceeded unfairly. Read More
The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
Hospira is voluntarily recalling more than 24,000 syringes of the injectable Amidate because out-of-specification results for degraded product were confirmed during stability testing. Read More
Despite industry concerns that ICH’s proposed new limits on metals are too strict, the organization released final guidance on elemental impurities in finished drugs that appears little changed from an earlier draft. Read More