Ethics/Regulatory

Congress Passes Long Awaited PDUFA Renewal Act

Monday, September 24, 2007 11:27 AM

The U.S. House and Senate passed the long awaited FDA Revitalization Act, a five-year renewal of the Prescription Drug User Fee Act of 1992 (PDUFA). PDUFA allows the FDA to collect fees from drug and device companies applying for regulatory approval. That law was set to expire on Sept. 30.

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Top Stories for the Week of August 27th 2007

Friday, August 31, 2007 07:52 AM

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Fraudulent Study Broker Cherie Thibodeau Continues to Bilk Sites

Friday, July 20, 2007 03:45 PM

As a public service to sites, CROs and biopharmaceutical companies, CenterWatch is posting a long excerpt of this week’s CWWeekly article about fraudulent study broker, Cherie Thibodeau.

If you have been defrauded of funds by Cherie Thibodeau, please contact CenterWatch at editorial@centerwatch.com.

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Top Stories for the Week of July 16th 2007

Friday, July 20, 2007 12:08 PM

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India to Allow First-in-Human Phase I Studies of Molecules Developed Abroad Soon?

Thursday, July 19, 2007 07:15 AM

India may allow first-in-human phase I studies of molecules developed abroad in the near future. Currently, India only allows first-in-human studies developed in India—a boon to the burgeoning domestic clinical research industry, and a bane of the global clinical research industry.

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AAHRPP Accredits 16 New Research Organizations

Thursday, June 28, 2007 05:58 PM

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited its largest group of institutions at one time in its six-year history. In total, 16 organizations gained AAHRPP approval. The certification is valid for three years. The AAHRPP is a non-profit organization that offers accreditation to organizations that conduct or review research with humans.

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Senate Okays PDUFA

Friday, May 11, 2007 02:15 PM

In a 93-to-1 vote, the U.S. Senate has approved a bill re-authorizing the U.S. Food and Drug Administration (FDA) to collect fees from drug companies to review investigational new drugs. The bill would also require that all phase II and later stage trials for both drugs and devices be listed on the government’s web site, www.clinicaltrials.gov.

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CMS Seeks To Revise Clinical Trial Coverage Rules

Tuesday, April 24, 2007 11:04 AM

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 12:13 PM

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 02:13 PM

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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