Medication management
The Food and Drug Administration Friday approved the first drug intended to treat smallpox, which was eradicated in 1980 but could be used as a bioweapon.
The Food and Drug Administration yesterday announced safety labeling changes for fluoroquinolone antibiotics to strengthen warnings about the risk of mental health side effects and serious blood sugar disturbances.
The House Ways and Means Committee today approved legislation (H.R. 6142) that would require the Health and Human Services secretary to develop with stakeholders a plan to reduce waste related to single-use drug vials.
The U.S. District Court for the Northern District of Mississippi has entered a consent decree prohibiting Delta Pharma from manufacturing or distributing compounded drugs until they comply with the Federal Food, Drug, and Cosmetic Act and FDA regulations.
Hospira is voluntarily recalling two lots of naloxone hydrochloride injection, used to treat opioid overdoses, because they may contain particulate matter on the syringe plunger, the Food and Drug Administration announced yesterday.
Medtronic has recalled more than 204,000 devices used to assist hospital and other patients with end-stage heart failure due to the potential for power source interruptions, the Food and Drug Administration reported Friday.
Food and Drug Administration Commissioner Scott Gottlieb, M.D., yesterday shared an update on the agency’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities.
The Food and Drug Administration today released two draft guidance documents aimed at reducing the ability of brand drug makers to use the agency’s Risk Evaluation and Mitigation Strategy programs as a way to block timely generic drug entry.
The AHA today submitted comments on the Food and Drug Administration’s Medical Device Safety Action Plan.
The Food and Drug Administration has approved special handling instructions to allow health care providers to use certain opioid and other intravenous drug products made by Hospira that were on hold due to low potential for a manufacturing defect but are in short supply.