Ethics/Regulatory

CMS Seeks To Revise Clinical Trial Coverage Rules

Tuesday, April 24, 2007

The Centers for Medicare and Medicaid Services (CMS) has proposed new coverage rules for payments to Medicare recipients involved in clinical trials. The rules would revise the agency’s Clinical Trial Policy’s national coverage determination (NCD) system and push additional transparency requirements on trial sponsors.

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EMEA Tightens Phase I Guidelines

Tuesday, April 3, 2007

The European Medicines Agency (EMEA) has drafted guidelines to help ensure the safety of subjects enrolling in first-in-man studies. The guidelines come on the heels of TeGenero’s trial, which caused six otherwise healthy phase I subjects to suffer severe adverse reactions after being administered an immunological agent at a hospital in the United Kingdom. Following the incident, reviews were performed on how the study was conducted and concluded it satisfied current regulatory requirements. Among the many items cited in the report, the EMEA recommends that the Minimal Anticipated Biological Effect Level—or MABEL—be used when testing “high risk products” such as monoclonal antibodies in phase I trials.

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The FDA On Madison Avenue

Wednesday, November 29, 2006

The Food and Drug Administration (FDA) has a deal in place that for the first time would allow pharma companies to pay fees for the FDA to review their drug advertisements. It is all being done in the hope of faster reviews. It’s not such a bad idea.

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Terrifying Budget Numbers

Friday, September 22, 2006

For all that consumers expect from the U.S. Food and Drug Administration, it is completely irresponsible of the federal government to fund it with less than $2 billion a year. By comparison, that’s exactly the same dollars the federal government is spending each week on the war in Iraq.

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FDA Offers Guidance on Informed Consent Exemptions

Wednesday, September 13, 2006

Helping to quell a storm of a controversy, the FDA has issued new guidelines describing the circumstances when informed consent can be waived for clinical trials in emergency or ambulatory settings. It’s a big issue. Informed consent is a ‘sacred cow’ in today’s clinical trial industry, and rightly so.

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Disapproving Look

Tuesday, September 5, 2006

Well, it’s about time the FDA took a hard look at the compounding of drugs at some pharmacies. Until now, the FDA sort of looked the other way at pharmacists who custom-blended drugs from bulk ingredients. Particularly popular have been custom hormone replacement therapies or drugs that remove an ingredient that may be an allergen.

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Adapting To A New Kind Of Trial

Monday, July 17, 2006

It’s great to see the FDA making a move this week to develop guidelines for adaptive clinical trials. Their time has come, given recent advances in scientific tools, such as toxicogenomic assays.

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