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The FDA hit Pfizer’s Hospira for failing to fully investigate quality defects, such as the presence of cardboard, in batches of injections and neglecting to take corrective measures. Read More
Former FDA deputy commissioner Scott Gottlieb emerged as the favorite to serve as the next leader of the FDA in a survey of 53 pharmaceutical companies. Read More
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More
The FDA is considering establishing a new office for patient affairs to support the agency’s efforts to engage patients in the drug development process. Read More
The administration’s plan to nominate Scott Gottlieb as FDA commissioner drew generally positive reactions on Capitol Hill and from drugmakers — but also some concerns from other stakeholders over his strong industry ties. Read More