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Two FDA advisory committees voted Tuesday that the benefits of a previously approved formulation of Opana ER no longer outweigh the risks of abuse. Read More
India’s Ministry of Health is proposing that drug regulators and drugmakers implement several measures to improve the quality of drugs in the country’s supply chain, following a government estimate that 10 percent of them are substandard. Read More
Companies want to be able to choose between providing quality metric reports on a more comprehensive product-by-product or less burdensome site-by-site basis. Read More
A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data integrity. Read More
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
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