News

The results of pilot programs focused on increasing international regulatory collaboration among the agencies that aim to enhance drug quality and safety globally, have been released by FDA together with its European and Australian counterparts.

American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the retail/hospital level. The company initiated the product recall because some vials may not maintain potency throughout their shelf-life.

FDA issued a warning this week that chronic high doses (400 mg/day to 800 mg/day) of fluconazole (Diflucan) during the first trimester of pregnancy may be associated with specific birth defects in infants. However, the risk does not appear to be associated with a single, low dose of fluconazole (150 mg), which is used to treat vaginal yeast infection (candidiasis), according to the Safety Alert released August 3.

The Office of Generics Drugs (OGD) has been reorganized to improve coordination, communication, efficiency, and to enhance the Office?s ability to assure that all generic drugs are safe, effective, high quality, and interchangeable to the brand name drug product/reference listed drugs, according to The Center for Drug Evaluation and Research (CDER), part of FDA.

FDA has issued a Complete Response Letter (CRL) for Intermezzo (zolpidem tartrate sublingual tablet, Transcept Pharmaceuticals).

Over the past 3 decades, pharmacists have become integrated members of multidisciplinary teams. To recognize the value of the role of pharmacists in improving patient outcomes and safety in cardiac care, the American Heart Association (AHA) will offer pharmacists a session focused specifically on them at this year?s AHA Scientific Sessions in Orlando, Fla.

PriCara and Ortho-McNeil, divisions of Ortho-McNeil-Janssen Pharmaceuticals, will operate under the name Janssen Pharmaceuticals, the family of companies announced this week. The change, effective immediately, is part of a global effort to unite the Janssen Pharmaceutical Companies around the world under a common identity and to increase collaboration, the statement said.

More than one-third of patients treated with everolimus (Afinitor) tablets had a 50% or greater reduction in the size of non-cancerous brain tumors associated with tuberous sclerosis complex (TSC) versus 0% who were treated with placebo, according to a company statement from the drug?s manufacturer Novartis.

A new report from the Institute of Medicine (IOM) recommends that 8 preventive health services for women will be added to the services that health plans will cover at no cost to patients under the Patient Protection and Affordable Care Act of 2010 (PPACA).

Improving glycemic control may help prevent heart failure, according to a recent study published in The Lancet. The study enrolled at 20,985 patients with type 1 diabetes to assess variables associated with cardiovascular disease, including age, sex, duration of diabetes, HbA1c, body mass index, systolic and diastolic blood pressure, LDL and HDL cholesterol, and smoking status.

FDA has approved a subcutaneous (SC)formulation of abatacept (Orencia, Bristol-Myers Squibb) for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA). It is the first biologic available in both SC and intravenous formulations for the treatment of RA.

FDA has issued a 90-day extension of the action date for Pfizer?s Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults 50 years of age and older.

FDA has received reports of serious central nervous system reactions when methylene blue is given to patients taking serotonergic psychiatric medications.

On August 9, Independence Blue Cross and Blue Cross Blue Shield of Michigan announced their alignment

Reform calls for establishment of the Consumer Operated and Oriented Plan, which permits new nonprofit insurers to offer plans in individual and small group markets

A new wave of exchange guidance is about to hit from the Center for Consumer Information and Insurance Oversight

To achieve a higher rate of clean claims, health plans have to be absolutely clear on what a "clean claim" means to all parties in the transaction.

Although Judy Cahill will end her term as CEO of the Academy of Managed Care Pharmacy next year, there's plenty to keep her busy between now and then.

A report shows that two out of five adult Americans have difficulty understanding the basic health information and services needed to make decisions.

As the struggle to halt healthcare costs continues, Maryland has uniquely managed to contain hospital reimbursement.

When it comes to big health plan payers, hospitals aren't feeling the love. That's the feedback from Revive Public Relations' fifth annual national payer survey.

Up to 30% of employers might drop employee coverage after 2014.

Mississippi consistently ranks low in health measures.

A main theme of new rules for state-based health insurance exchanges is flexibility for states.

Private healthcare premiums increased by nearly 15% from $697 billion to $801 billion between 2005 and 2009, reports the National Institute for Health Care Management.

There's a bill working its way through California that would require health plans to standardize their prior authorization paperwork.

Oregon Governor John Kitzhaber signed legislation that will transition the state's Medicaid fee-for-service to care coordination

About 1 in 10 computer-generated prescriptions includes at least 1 error, and one-third of those has potential for harm, which is consistent with the error rate for paper-written prescriptions, according to a new study published online June 29 in the Journal of the American Medical Infomatics Association.

A smoking cessation program in which participants received mobile phone motivational text messages significantly improved smoking cessation rates at 6 months and the method should be considered for inclusion in smoking cessation services, according to a study published June 29 in The Lancet.

The US Centers for Disease Control and Prevention (CDC) has released revised recommendations for postpartum contraceptive use based on an assessment of new evidence, according to an article published in the July 8 issue of Morbidity and Mortality Weekly Report.