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The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
Just days after the Trans-Pacific Partnership pact cut exclusivity protections for drugmakers outside the U.S., a proposal that would extend a waiver allowing poor countries to ignore drug patent laws is raising more ire. Read More
The FDA handed Galena Biopharma a 10-item Form 483 for lapses in adverse drug event reporting — some of them repeat observations — following a reinspection of its Portland, Ore., facility. Read More