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Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. Read More
It took Luitpold Pharmaceuticals subsidiary PharmaForce in some instances months to close investigations into out-of-specification results, leading to a Form 483 from the FDA. Read More
Inadequate validation studies and complaint investigations resulted in a new Form 483 for Hospira, which has struggled with quality issues over the past few years. Read More
With a deadline looming, the pharmaceutical industry still needs to decide which data systems are most efficient and cost-effective for implementing the federal track-and-trace law, experts say. Read More
The FDA now has the power to stop any pharmaceutical import it suspects could be adulterated or misbranded, according to a final rule that implements the agency’s new import authority. Read More
British authorities continue to investigate 21 cases of blood poisoning in babies who received potentially contaminated batches of an intravenous liquid feed at neonatal intensive care units in England, but said the manufacturer of the product was following GMP guidelines. Read More
Alexion is pulling more of its flagship product Soliris from the market due to visible particles that arose from a manufacturing problem, the third recall in less than a year. Read More
Companies throughout the drug supply chain that encounter suspected counterfeit products should file a report with the FDA and any affected trading partner within 24 hours, the agency says. Read More
The FDA expects to start collecting manufacturing quality metrics data from drugmakers sometime in 2015, a move agency officials say will cost manufacturers little but pay off in the potential for fewer inspections. Read More
The generic drug industry wants the FDA to ensure new requirements for packaging and technologies aimed at curbing opioid abuse don’t result in barriers to market entry for generic makers. Read More