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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
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
A leaked draft of the Trans Pacific Partnership trade agreement gives far too much intellectual property protection to brand drugmakers at the cost of generic competition, GPhA said Wednesday in a letter to the Obama administration. Read More
China’s FDA is threatening to severely punish companies that illegally manufacturer and sell codeine in the country, a warning the follows several revelations of the product was being sold in bulk quantities. Read More
The FDA wants manufacturers to stop sending paper prescribing information to pharmacists and physicians who often don’t read it and only submit it electronically to the agency, a move that would create a single source for accurate labeling that would always be up to date. Read More