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Archive for the ‘ FDA ’ Category

Survey: Lack of funds, regulatory climate threaten biomedical industry

Friday, January 13th, 2012

Future growth for the biomedical industry faces growing and unprecedented threats, according to a newly released survey of CEOs from life sciences companies in California, the largest biomedical cluster in the world. The three biggest threats reported were access to capital, a burdensome and uncertain regulatory environment, and lack of ...

Posted in FDA, Uncategorized, clinical trials, drug discovery | No Comments »

Quintiles backs innovative breast cancer trial

Thursday, April 14th, 2011

Today, Quintiles got into the "spy" game - the I-SPY 2 clinical trial, to be exact. The contract research organization has committed a total of $2.6 million over four years to support the trial, formally known as the "Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular ...

Posted in CRO, FDA, clinical trials, drug discovery | No Comments »

Co-development guidance sets road map, but hurdles remain

Tuesday, January 18th, 2011

You have about a month left to weigh in publicly, if so moved, on FDAâ€™s new draft guidance on the co-development of drugs designed for use in combination therapy. Deadline for written comments is Valentineâ€™s Day. The agency, in its guidelines released before the holidays, acknowledged the need for a ...

Posted in FDA, cancer, clinical trials, drug discovery | No Comments »

Hands-on training for SDTM conversion

Wednesday, March 10th, 2010

With FDA's adoption of a standardized data file format for clinical data submissions, clinical researchers need to know these new standards when collecting and preparing their clinical trial data for submission, since it is the only way that clinical data can be submitted. The ultimate purpose of using the Study ...

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