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Category Archives: Clinical Trials
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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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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August 2011 FDA Guidances
Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the … Continue reading
Divisive Devices or UFC 510(k): FDA Meets IOM
In a previous post, I discussed the FDA’s Center for Devices and Radiological Health (CDRH) re-evaluation of the 510(k) review process for medical devices. This re-evaluation, spearheaded by the very visible director of CDRH, Dr. Jeffrey Shuren, was prompted by … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged 510(k), CDRH, clinical trials, FDA, manufacturing, medical devices, PMA, postmarketing, safety
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