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Latest From Michael Cipriano
Inspirion's oxycodone is first immediate-release opioid approved with abuse-deterrent language in labeling.
US agency's events could address a touchy subject: how much responsibility does FDA have for preventing adverse events, and how much falls to physicians?
Joint ordinance signed by Anvisa and INPI hopes to resolve a 16-year impasse between the two agencies and bring predictability to patent application process; Anvisa will be relegated to analyzing public health matters, while INPI will make final patentability determinations.
FDA should consider allowing sponsors in challenging area of single species antibacterials more flexibility in study designs, advisory committee suggests, despite disagreement over approaches such as animal models and non-inferiority trials.
Panelists at US FDA advisory committee on Inspirion's RoxyBond note reservations about abuse-deterrent claims absent more real-world data on how they work; FDA's Staffa suggests agency is eager to see how well premarket work predicts postmarket experience – though the data are far from being available.
US agency’s advisory committee will weigh the pros and cons of five possible development and regulatory pathways, with a specific focus on animal models.