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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
Indian generics maker Lupin Pharmaceuticals is being sued by Valeant Pharmaceuticals subsidiary Bausch + Lomb and Senju Pharmaceuticals over its ANDA for Prolensa eye drops. Read More
The FDA is seeking a permanent injunction against a California drugmaker, saying the company manufactures and distributes over-the-counter vaginal products without proper regulatory approval. Read More