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Tag Archives: FDA
FDA Issues New PDF Specifications
In the chaos of the holidays, you might have missed the release of an important new guidance from FDA. On 20 December 2011, FDA issued version 3 of “FDA Portable Document Format (PDF) Specifications,” fulfilling a promise made at … Continue reading
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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Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies
Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval. The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET. Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged biomarkers, Cato Research, clinical trials, drug development, EMA, FDA, pharmacodynamics, pharmacokinetics, Phase 1, Phase 2, pivotal studies, regulatory strategy, webinar
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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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Pre-IND Submissions in eCTD Format
Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission. However, since FDA assigns a Pre-IND number, which ultimately becomes the IND … Continue reading
