Ethics/Regulatory

CenterWatch Commentary: Experimental Drug Access Wars Continue

Friday, August 22, 2008 09:00 AM

A U.S. District judge Wednesday ordered PTC Therapeutics to supply its experimental drug to 16-year-old Jacob Gunvalson, who has Duchenne muscular dystrophy, a terminal disease for which there is no known cure.

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CenterWatch Monthly July 2008 Issue

Tuesday, July 15, 2008 06:00 AM

Maine Moves First with Clinical Trial Transparency Law

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Terrifying Budget Numbers

Friday, September 22, 2006 03:52 PM

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 04:50 PM

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 09:54 AM

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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The Right To Use Unproven Treatments?

Tuesday, August 8, 2006 03:11 PM

It’s ironic that at a time when several high-profile marketed drugs have been given a black box warning or withdrawn from the market that the Abigail Alliance has gathered steam.

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Adapting To A New Kind Of Trial

Monday, July 17, 2006 11:29 AM

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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