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FDA approves temporary import of hydromorphone hydrochloride injection
The Food and Drug Administration recently authorized the temporary import of hydromorphone hydrochloride injection from Canada to address a critical shortage of the drug, an opioid pain medication.
FDA issues guidance to facilitate greater generic drug competition
The Food and Drug Administration Friday released draft guidance on how drug developers can apply for the agency’s Competitive Generic Therapies designation.
FDA Announces Action to Relieve Opioid and Other IV Drug Shortages
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.
AHA Voices Support for FDA Plan to Improve Medical Device Security
The AHA today submitted comments on the Food and Drug Administration’s Medical Device Safety Action Plan.
FDA Issues Update on Actions to Address Drug Shortages
Shortages of intravenous saline and other fluids are beginning to improve, according to the Food and Drug Administration.
House Bills to Study Drug Vial Waste, MA Payment Adjustment Advance
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.
FDA Issues Draft Guidance to Reduce Blocking of Timely Generic Drug Entry
The Food and Drug Administration today released two draft guidance documents aimed at reducing the ability of brand drug makers to use the agency’s Risk Evaluation and Mitigation Strategy programs as a way to block timely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.
FDA Provides Update on Work to Mitigate Shortages of IV Drugs
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.
Medtronic Recalls Heart Failure Device
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.
Hospira Recalls Certain Naloxone Injection Products
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.