Ethics/Regulatory

Roche seeks compromise with FDA over Avastin

Monday, August 8, 2011 01:41 PM

In a bid to salvage the breast cancer indication for Avastin, Roche’s Genentech unit has pitched to the FDA what it is calling a “middle-ground proposal” that would allow the drug to retain its indication and only for use with paclitaxel. The deal includes revised labeling in which Avastin would be recommended only for patients displaying “aggressive disease” and who have the fewest treatment options. Roche also suggests a Risk Evaluation and Mitigation Strategy, or REMS, as well as a Medication Guide, according to Pharmalot.

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Merck receives subpoena regarding marketing and selling of drugs

Monday, August 8, 2011 01:34 PM

Merck has received a subpoena from the US Department of Justice as part of a criminal investigation into the marketing of various drugs. The feds want info about marketing and selling these drugs - Temodar, which treats brain tumors; the PegIntron hepatitis C treatment; and Intron A, which treats certain cancers - from 2004 through the present, according to Pharmalot.

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Survey: training needed for India’s growing clinical trial industry

Friday, August 5, 2011 10:44 AM

India needs to tackle regulatory delays and introduce “comprehensive and ongoing” training of clinical investigators if it is maximize the country’s potential as a destination for international clinical trials, the results of a recent survey suggest, according to PharmaTimes.

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Essex scolded by FDA after phony clinical trial sponsor

Thursday, August 4, 2011 12:08 PM

Earlier this year, the FDA has issued an alert that some fictitious applications were submitted to several Institutional Review Boards. The agency noted that the name and address of the clinical investigator listed on a required FDA form are the same as that used in a sting operation conducted by the US Government Accountability Office two years ago, according to Pharmalot.

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Cetero says FDA’s actions ‘difficult to understand’—company notified agency of chemists’ misconduct

Monday, August 1, 2011 08:02 AM

Large, early-phase CRO Cetero Research seemed blindsided by the FDA’s letter to the company last week accusing it of falsifying data and manipulating samples over a five-year period at its Houston bioanalytics lab.

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Critics raise concerns over research, incentives of European pediatric exclusivity regulations

Monday, August 1, 2011 08:00 AM

Regulations introduced four years ago in Europe to encourage research into medicines for children have lead to important therapeutic breakthroughs for pediatric patients.  Yet concerns also have been raised about how well the system works.

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Pearl IRB, Trafalgar Ethics Board join forces

Thursday, July 28, 2011 11:50 AM

With the multi-center global clinical trials trend continuing to grow, the U.S. and Canada accounted for 60.5% of sponsored trials in 2010. To deliver integrated U.S.-Canada study reviews, Pearl IRB, based in Indianapolis, and Toronto-based Trafalgar Ethics Board have joined forces.

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FDA inspections find Cetero faked records, manipulated samples

Wednesday, July 27, 2011 01:43 PM

Drug companies that had medicines tested by contractor Cetero Research might have to re-evaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples, according to Reuters.

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Insufficient advisory board members due to conflict-of-interest rules

Wednesday, July 27, 2011 01:19 PM

Conflict-of-interest rules restricting scientists with financial ties to drug and device- makers from advising U.S. regulators may loosen next year, said FDA Commissioner Margaret Hamburg, according to Bloomberg News.

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Government proposes rule changes on human research

Monday, July 25, 2011 01:58 PM

The government is proposing changes in the rules covering research involving human subjects, an effort officials say would strengthen protections while reducing red tape that can impede studies, according to The New York Times.

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