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Baxter and Sagent Pharmaceuticals are the latest generic drugmakers to recall products with leaky containers, notifying healthcare providers that affected product may be contaminated with particulates. Read More
Drugmakers in the EU are pushing back against a proposal moving through the EU Parliament that would grant clinical trial participants the right to demand that their trial data — including data shared between regulators and other entities — be deleted. Read More
Sponsors should gather supportive data from two definitive clinical trials to establish efficacy for drugs proposed to treat chronic fatigue syndrome/myalgic encephalomyelitis, the FDA says. Read More
Indian generics makers Sun Pharma and Ranbaxy are both facing individual Class II U.S. recalls related to product mixups. Both recalls were included in the FDA’s March 5 enforcement report. Read More
The European Medicines Agency (EMA) is calling on EU makers of seasonal influenza vaccines to develop enhanced safety signal monitoring systems that identify increases in allergic reactions, moving away from systems that simply check for specific batch deviations. Read More
Pfizer is recalling three lots of drug products after a packaging mix-up led to a capsule of the wrong drug product in a bottle of an antidepressant. Read More
Concerns with particulates in injectable drugs is plaguing Agila Specialties again as the Mylan unit Feb. 19 revealed that its Polish plant is at the center of a recall of an anesthetic product. Read More
Porcine trypsin (PTy), a starting material used in biologic drugs, should be tested just after it is produced to ensure material from a single infected pig doesn’t enter production batches, EU regulators say. Read More
The FDA and European Medicines Agency (EMA) are extending for two years a pilot program for joint reviews of quality-by-design (QbD) applications, saying the program has helped both agencies develop guidance in this area. Read More
Sagent Pharmaceuticals is the latest drugmaker to recall products with leaky containers, notifying healthcare providers that two lots of its Zoledronic Acid Injection product may not be sterile after finding that four premix bags had been compromised. Read More
Beginning on June 16, whenever a drugmaker receives approval for a new drug by an EU member state, it will have 15 calendar days to report the approval to the EMA’s new centralized electronic registry. Read More