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There is currently no evidence of increased rates of death or heart attack from drug-eluting stents versus bare-metal stents, but more trials with consistent protocols are needed to adequately assess the risk, an FDA panel concluded last month.
After examining risks related to the off-label use of drug-eluting stents, an FDA advisory panel last month recommended the agency consider mandating labeling changes.
The FDA issued an approvable letter for Nuvo’s topical non-steroidal anti-inflammatory drug Pennsaid to treat osteoarthritis of the knee, the company announced.
The process for institutional review boards (IRBs) to refer potentially high-risk clinical trials involving children to the FDA for special review is laid out in detail in a new guidance document.
The FDA is pledging to continue fighting an effort by wholesalers to stop the agency from implementing its drug-tracking rule, despite early setbacks in court.
Instead of the new regulatory authority being proposed by lawmakers and embodied in a recent study by the Institute of Medicine, the FDA actually needs money to improve the science of regulation, according to the agency’s outgoing deputy commissioner for medical and scientific affairs.
While voicing their support for the FDA’s all-electronic submission system proposal, industry leaders are warning that the agency has a lot to consider before going forward.
Dupaco violated current good manufacturing practices by not performing required tests or following complaint procedures with its blood/fluid warming sets, according to an FDA warning letter.