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Tag Archives: safety
Fifth China Medicinal Biotech Forum – Conference Recap
I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011. The purpose of this conference was to update graduate students in China on the latest trends in biotechnology. This forum also allowed … Continue reading
Posted in Clinical Trials, Conferences and Meetings
Tagged biologics, biosimilar, biotech, China, clinical research, clinical trials, conference, DNA, efficacy, FDA, gene therapy, immuno, manufacturing, monoclonal antibody therapy, NIH, Phase 1, recombinant proteins, safety
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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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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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Free Educational Webinar – New Rules in FDA Safety Reporting: Are You Prepared?
UPDATE: The slides from the webinar are now available for download here. Please join us on Wednesday, 15 June (10:00 AM EDT) as we focus on the FDA’s new rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and … Continue reading
Posted in Clinical Trials, Webinars
Tagged adverse events, bioavailability, bioequivalence, clinical trials, FDA, guidance, IND, pharmacovigilance, safety, webinar
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