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Tag Archives: toxicology
Project Management for Biotech Companies
In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success. Large organizations understand the value that project management can contribute to a successful project. The smaller companies tend to … Continue reading
Posted in Clinical Trials, Project Management, Regulatory Strategy
Tagged biotech, Cato Research, central labs, clinical investigator, clinical research, clinical trials, CMC, CROs, drug development, drug product, efficacy, enrollment, FDA, GCP, GLP, GMP, ICH, manufacturing, nonclinical research, project management, protocol, safety, site selection, SOP, stability, toxicology
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New FDA Guidances – September 2011
Here’s a list of the notable guidances released by FDA in September 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Reproductive and Developmental Toxicities – Integrating Study Results to Assess Concerns User Fee Waivers, Reductions, and Refunds for Drug … Continue reading
Posted in FDA, Regulatory Strategy
Tagged FDA, guidance, marketing, toxicology, validation
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FDA Reorganizes Oncology and Hematology Divisions
When we are no longer able to change a situation, we are challenged to change ourselves. Victor Frankl The FDA recently announced that it is reorganizing three divisions (Hematology Products, Drug Oncology Products, and Biologic Oncology Products) from the Office … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged CDER, FDA, hematology, marketing application, oncology, toxicology, tumors
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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 – 2011 Society of Toxicology Annual Meeting
The Society of Toxicology’s (SOT) 50th Anniversary Annual Meeting was held on 05-10 March 2011 in Washington, DC. Several members of Cato Research’s Nonclinical Sciences Development group were amongst the more than 7,000 toxicologists from 50 countries in attendance this … Continue reading
Posted in Conferences and Meetings
Tagged FDA, Margaret Hamburg, NIH, nonclinical research, preclinical, safety, toxicology
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