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Tag Archives: cancer
New Guidances from FDA – June 2011
Here’s a list of the guidances released by FDA in June 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Q11 Development and Manufacture of Drug Substances (Draft) Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Draft) … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biologics, cancer, Cato Research, FDA, guidance, IDE, in vitro diagnostics, manufacturing, medical devices, OTC, PMA
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Bridging the Valley of Death: Bringing New Drugs from the Bench to the Clinic
To bring a new medicine to the stage of clinical trial testing requires on the order of $500,000 to one million dollars and then seven to ten years of clinical trials and around $800 million dollars before getting to market. … Continue reading
Posted in Clinical Trials, Venture Capital
Tagged biotech, cancer, Cato BioVentures, clinical trials, CROs, drug development, funding, NIH, Phase 1, Phase 2, preclinical, toxicology, venture capital
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Conference Recap – Biomarker World Congress 2011
Everywhere in the news today, we hear that we are in the era of personalized medicine – where new medicines will be tailor-made for individual patients. Specifically, personalized medicine is dedicated to the concept hat the right drug is … Continue reading
Posted in Clinical Trials, Conferences and Meetings
Tagged biomarkers, breast cancer, cancer, Chemotherapy, clinical trials, efficacy, oncology, personalized medicine, Phase 1, Phase 2, validation
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Clinical Trials in South Africa 101
South Africa has a mixture of both first and third world diseases and a large number of experienced research sites, making the country an excellent location for clinical trials in many indications. As we are a southern hemisphere country, recruitment … Continue reading
Recap of the NCCN 16th Annual Conference
The 16th Annual National Comprehensive Cancer Network Conference (NCCN): Clinical Practice Guidelines and Quality Cancer Care, was held on 09-13 March 2011 in Hollywood, FL. The conference hosted almost 2,000 registrants including oncologists, nurses, pharmacist, and other health care professionals. … Continue reading
Posted in Conferences and Meetings
Tagged cancer, clinical trials, conference, FDA, oncology
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