FDA

United BioSource Continues to Grow with Purchase of Gigamoto Technology

Wednesday, September 23, 2009 06:28 AM

United BioSource Corporation (UBC) completed its second acquisition in two weeks with the purchase of Gigamoto Technology Partners, a Pennsylvania-based software company specializing in drug safety and risk management, for an undisclosed sum.

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FDA Launching New Rules to Expand Access to Investigational Drugs

Thursday, August 27, 2009 09:16 AM

The U.S. Food and Drug Administration published two new rules to help seriously ill people gain access to investigational drugs when they are not eligible for clinical trials and have exhausted other treatment options.

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ACRO: Global Clinical Trials Benefit Drug Development

Tuesday, July 28, 2009 07:14 AM

A new report released last week by the Association of Clinical Research Organizations (ACRO) says clinical trials conducted in the developing world not only match the quality and safety standards of those conducted in the developed world but they also improve the global drug development process.

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FDA Debars Two Clinical Investigators Six Years after Fraud Convictions

Wednesday, July 15, 2009 07:27 AM

More than six years after being convicted of fraud, two medical researchers were recently barred from working as clinical investigators by the U.S. Food and Drug Administration (FDA).

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CenterWatch Monthly June 2009

Friday, June 5, 2009 09:17 AM

U.S. Sites Rate Medpace, Kendle, ICON as Top CROs in 2009

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Coast IRB to Close in Wake of GAO Investigation

Monday, April 27, 2009 09:31 AM

Coast IRB, the institutional review board (IRB) that was the target of an undercover investigation by the Government Accountability Office (GAO), is closing its doors, according to reports published last week.

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Coast IRB Halts New Study Submissions

Wednesday, April 15, 2009 07:53 AM

Facing FDA concerns about its ability to protect human subjects participating in clinical trials, Coast Institutional Review Board has voluntarily suspended the approval of new studies as well as the recruitment of new patients for ongoing studies.

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IRB Uncovers Congressional 'Sting' Operation

Monday, March 23, 2009 09:00 AM

Source: Coast IRB

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Guest Commentary: Suicidality Monitoring in Pharmaceutical Clinical Trials

Friday, March 20, 2009 08:00 AM

Dr. Michael McKelvey, CEO of ERT , a leading provider of centralized ECG and eClinical technology, ePRO, and other services to the biopharmaceutical, medical device, and related industries, discusses the benefits of electronic patient reported outcomes (ePRO) tools for assessing and monitoring suicidality in clinical drug trials.

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Duke, NEJM Study Renews Debate on Global Outsourcing

Thursday, February 19, 2009 04:29 PM

The ethics and safety behind the global outsourcing of clinical trials is once again being debated, with the release of a new study reporting that U.S. drug developers conduct most of their late-stage drug trials outside of the United States.

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