Regulatory Affairs Syndicator

Cipher reports 2006 third quarter resultsCNW Telbec (Communiqués de presse), Canada - 27 minutes ago… Drug Application (NDA) for CIP-TRAMADOL ER, a sustained-release tramadol formulation, accepted for review by US Food and Drug Administrat…

Researchers report an inverse relationship between antidepressant prescriptions and the rates of suicide in children and adolescents — a finding that contradicts the Food and Drug Administration’s “black box” …
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In a recent Public Health Advisory, FDA summarized two new studies that practitioners should consider when making decisions about prescribing SSRIs and other antidepressant medications for pregnant women and those planning a pregnancy.

The first…

Cardinal Health, the owner of Alaris Products, has recalled all models of the Alaris Signature Edition (or SE) infusion pumps. These pumps have a design defect called “key bounce” that may cause over-infusion of medications. The affected models are…

FDA is notifying healthcare professionals that certain human tissues used in patients may have an increased risk for transmitting infectious diseases. These tissues, including human bone and soft tissue such as tendons, came from a tissue recovery c…

A recent FDA article describes another case of mix-ups between two drugs whose names look and sound alike. Mucinex is an OTC extended-release guaifenesin tablet used as an expectorant. Mucomyst (acetylcysteine) is approved in its inhaled form as a …

A recent Institute for Safety Medication Practices report alerted readers to the possibility of patient death if azathioprine, an immunosuppressant, and mercaptopurine, an antimetabolite, are given together. The report points out that mercaptopurine…

The Institute for Safe Medication Practices recently reported on several mix-ups between two vaccines. The first is DAPTACEL, which is diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP). The second is ADACEL, which is te…

FDA is alerting healthcare professionals that taking 400 mg of ibuprofen can interfere with the antiplatelet effect of low dose aspirin i.e., the 81 mg of aspirin per day taken by many patients for its cardioprotective effect. Because of this interf…

Pfizer Drug Dealt Blow in TestingNew York Times, United States - 35 minutes ago… But doctors said that the blood pressure rise was medically significant and would discourage the Food and Drug Administration from approving torcetrapib, even …

WTOL-TV - An official from the federal Food and Drug Administration says the outbreak appears to be over and there is little evidence of any ongoing risk. Copyright 2006 Associated Press. All rights reserved. This material may not be published, broadcast …

CNNMoney.comSanofi's Weight-Loss Drug May Be Victim of German Health CutsBloomberg - 9 hours ago… Food and Drug Administration approval of Acomplia may be delayed until 2007 after the company didn't confirm its goal to introduce the prod…

East Bay Business Times - The Food and Drug Administration accepted Bionovo Inc. ’s protocol for an early-stage clinical trial of BZL101, a drug for metastatic breast cancer. Emeryville-based Bionovo (OTCBB: BNVI) said Tuesday that the Phase I/II trial will be run at 10 …

ABC6.com - The Food and Drug Administration’s Center for Food Safety and Applied Nutrition says reports of illness peaked in late September, suggesting the outbreak is now over. It says there is little evidence of any ongoing risk. Connecticut health officials …

Woman died in E. coli outbreak A Seattle law firm has filed a lawsuit in Sarpy County District Court on behalf of a Bellevue woman who died from complications of E. coli.
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