Content about Regulatory and Washington

December 21, 2011

Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

December 20, 2011

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

December 20, 2011

The Pharmacy Technician Certification Board on Tuesday announced a push to inform patients with practical solutions on how to best utilize remaining 2011 flexible spending account funds.

December 20, 2011

The Council for Responsible Nutrition and VIRGO on Tuesday announced details for an industrywide webinar to examine key elements of good manufacturing practices for dietary supplements and offer advice as to what the industry can do to improve its record of inspections.

December 19, 2011

The Food and Drug Administration has approved a drug for treating high blood pressure made by Mylan, FDA records showed.

December 19, 2011

The Food and Drug Administration has approved a drug made by Sandoz for treating yeast and other fungal infections.

December 16, 2011

The Electronic Retailing Self-Regulation Program on Wednesday recommended that Emergent Health modify or discontinue certain Internet advertising claims for the company’s “JDI MultiVitamin,” promoted by the advertiser as designed to “increase adult stem cells.”

December 16, 2011

ViroPharma has received approval for updated labeling to its antibiotic drug.

December 16, 2011

The Obama administration on Thursday issued an interim final rule that will help prevent prescription drug shortages.

December 16, 2011

A new bipartisan bill introduced in the Senate seeks to protect consumers from Internet drug sellers posing as legitimate pharmacies.

December 15, 2011

Approximately 5.3% of high school seniors abused over-the-counter cough-cold medicines in the past month, according to the latest "Monitoring the Future" survey released Wednesday by the National Institute on Drug Abuse.

December 15, 2011

A Food and Drug Administration expert panel will review a drug made by NeurogesX as a potential treatment for pain associated with HIV.

December 15, 2011

The Generic Pharmaceutical Association proposed Thursday the creation of a new initiative to combat the problem of drug shortages.

December 15, 2011

The National Association of Chain Drug Stores and National Community Pharmacists Association issued a statement on Thursday announcing that they commend Reps. Bruce Braley, D-Iowa; Mike Rogers, R-Mich.; and 38 of their colleagues who expressed concerns with draft Federal Upper Limits lists that recently have been published by the Centers for Medicare and Medicaid Services.

December 15, 2011

A group of Medicine Shoppe International and Medicap franchise owners is filing claims against the two companies over an alleged breach of contract and failure to support the franchise systems.

December 14, 2011

The Centers for Disease Control and Prevention and the Consumer Healthcare Products Association Educational Foundation on Tuesday launched the Up and Away and Out of Sight educational program to help educate parents on the importance of keeping their medicines in a safe place from children.

December 14, 2011

A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.

December 14, 2011

The National Association of Chain Drug Stores on Wednesday challenged some of Express Scripts' and Medco's testimony during last week's hearing before the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, most notably that PBMs are subject to state regulation in all states and that as a PBM the two companies have no influence on the design of prescription drug benefits.

December 14, 2011

North Carolina may be two years away from joining Oregon and Mississippi as the only states to classify pseudoepehdrine as a prescription-only medicine.

December 13, 2011

The Federal Trade Commission has voted to approve Valeant's acquisitions of Dermik, a unit of French drug maker Sanofi that makes drugs for skin conditions, and Ortho Dermatologics, a division of Johnson & Johnson that also makes skin drugs.

December 13, 2011

The Department of Health and Human Services on Monday announced that the first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic.

December 13, 2011

A new law in Washington state intended to curb accidental deaths related to opioid painkillers is having some adverse side effects, according to published reports.

December 13, 2011

New York state Gov. Andrew Cuomo has signed into law a bill that would forbid health insurers from requiring plan members to order prescription drugs from mail-order pharmacies, according to published reports.

December 12, 2011

The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

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