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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
Injectables maker Hospira is facing yet another recall after a customer found particulates embedded in a vial of 0.5 percent Marcaine painkiller. Read More
European drugmakers are praising the European Commission’s plans to increase enforcement of intellectual property rights in the EU and developing world over the next two years, saying they are important to ensuring EU innovation and economic competitiveness. Read More
Teva is still fighting to keep generic versions of its blockbuster multiple sclerosis drug Copaxone off the market, with its seventh citizen’s petition asking the FDA to mandate that any ANDA on the product undergo extra levels of bioequivalence testing. Read More
Tramadol manufacturers have approximately 45 days to implement new labeling and security procedures now that the Drug Enforcement Administration has determined the opioid analgesic is a Schedule IV controlled substance. Read More