Medication management

Jul 19, 2018
The American College of Emergency Physicians and Medical Association of Georgia this week filed a federal lawsuit seeking to compel Anthem's Blue Cross Blue Shield of Georgia to rescind a policy that retroactively denies coverage for emergency patients. According to the lawsuit, the policy violates…
Jul 16, 2018
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. “This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” said FDA Commissioner Scott Gottlieb, M.D.…
Jul 11, 2018
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. Based on a recent FDA review of adverse event reports and the medical…
Jun 21, 2018
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, and report to Congress on options for any needed legislative action to…
Jun 11, 2018
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, the Food and Drug Administration announced…
Jun 5, 2018
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. The lots were distributed to hospitals, wholesalers and others in…
Jun 4, 2018
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. The HeartWare Ventricular Assist Device is used as a bridge to cardiac…
Jun 1, 2018
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. Among other actions, Gottlieb said FDA is “evaluating our current authorities to…
May 31, 2018
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 first document provides guidance on the…
May 24, 2018
The AHA today submitted comments on the Food and Drug Administration’s Medical Device Safety Action Plan. Released in April, the plan outlines new pre- and post-market authorities, guidance and an expert board under consideration by the agency to improve device security and how device makers…