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Lax procedural documentation in quality control units topped the list of reasons why drugmakers received Form 483s in fiscal 2014, its ninth consecutive year at the top, while poor laboratory controls jumped to second place from fourth in the annual rankings of inspection observations. Read More
New Zealand’s regulatory authority is updating its uniform recall procedure for drugs, following a recent decision not to pursue a joint regulatory agency with Australia. Read More
AstraZeneca’s first-in-class ovarian cancer drug Lynparza will soon be available in Europe, following European Medicines Agency approval late this week. Read More
The FDA has cleared Alcon Research’s eardrop Xtoro for acute otitis externa infection, marking the agency’s first new approval of a flouroquinolone antibiotic. Read More
Veloxis Pharmaceuticals has filed a lawsuit demanding the FDA grant final approval of its extended-release immunosuppression drug Envarsus, which is being held up by the exclusivity of a rival product. Read More
The FDA is considering employing unmanned aerial drones to aid in facility inspections, although it’s unclear whether that would encompass drug manufacturing plants. Read More
The FDA’s proposal to survey pharmacists and patients on how changes to the physical appearance of a therapy may affect patient perceptions and drug adherence is raising concerns among both brand and generic drug manufacturers. Read More
The FDA has approved 35 novel new drugs so far this year, up from 27 products last year, with officials touting 2014 as the best year ever for rare disease treatment approvals. Read More
In two years’ time, manufacturers must submit applications for NDAs, ANDAs, INDs and BLAs using a set of approved electronic formatting standards, which the FDA finalized yesterday. Read More
The Justice Department has charged two people with murder and 12 others with serious crimes over alleged manufacturing violations at the New England Compounding Center (NECC) that led to 64 deaths due to meningitis and sparked a federal law to reign in large compounders. Read More