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Tag Archives: marketing application
Recap of the DIA Annual Meeting 2011
The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, … Continue reading
Posted in Uncategorized
Tagged AIDS, biologics, biosimilar, Cato Research, CBER, CDER, clinical trials, DIA, EMA, EU, FDA, follow-on biologics, generic drugs, geriatric, GMP, guidance, HIV, marketing application, oncology, Orphan Drug Designations, pediatric, pharmacovigilance, pre-IND
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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
2010 New Drug Approvals
The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 21 new products in 2010 – slightly less than the previous year’s 24 – plus 5 biologics approved by CBER. In light of the FDA’s continued focus on drug safety, I am not surprised that the number isn’t higher. A full list of approvals can be found here.
While the list isn’t long, a few new products stand out to me. Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biologics, BLA, cancer vaccine, CBER, CDER, clinical trials, FDA, marketing application, monoclonal antibody therapy, NDA, safety, vaccines
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Download the Slides from the Data Quality and Integrity Webinar
Yesterday’s free webinar, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval,” was a great success! For those who would like them, the slides from the presentation are now available for download here (PDF file). Stayed tuned Ask-Cato.com for … Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged Cato Research, clinical study report, clinical trials, data standards, drug development, marketing application, regulatory affairs, webinar
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Data Quality and Integrity: From Clinical Monitoring to Marketing Approval
At 2:00 PM ET on Thursday 18 November 2010, Cato Research will host a webinar titled, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval.” The webinar will be presented by Nancy Detich, Ph.D., a Senior Clinical Strategy Scientist … Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged Cato Research, clinical study report, clinical trials, data standards, drug development, marketing application, regulatory affairs, webinar
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