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Monthly Archives: April 2010
Cato at BIO 2010
The BIO International Convention is the largest global event for the biotechnology industry. It attracts the biggest names in biotech, offers key networking and partnering opportunities, and provides insights and inspiration on the major trends affecting the industry. This year’s … Continue reading
Posted in Conferences and Meetings
Tagged BIO, BIO 2010, biotech, Cato BioVentures, Cato Research, Chicago, CROs, Quebec
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First Example of Proposed DTC Rules in Effect?
No one can possibly know what is about to happen: it is happening, each time, for the first time, for the only time. – James Arthur Baldwin Hey, remember those proposed DTC advertising rules that the FDA published recently? Well, … Continue reading
Posted in FDA, Industry News
Tagged advertising, DDMAC, direct to consumer, DTC, FDA, guidance, warning letters
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FDA-TRACK – The FDA’s FDA-Tracking System
Data is what distinguishes the dilettante from the artist. – George V. Higgins In another move on its transparency initiative, the FDA has recently announced a new program to publicly track its own performance. It’s called FDA-TRACK and, in the … Continue reading
Posted in FDA, Industry News
Tagged BLA, CBER, CDER, CDRH, FDA, FDA-TRACK, IND, NDA, postmarketing, transparency
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Blockbuster Sales Forecasts for 2010 and 2014
The most reliable way to forecast the future is to try to understand the present. – John Naisbitt Interested in what blockbuster drug sales may be like for the next 4 years? Trying to position your developing therapeutic against the … Continue reading
Posted in Industry News
Tagged Amgen, AstraZeneca, blockbuster drug, forecasts, GSK, Merck, Novartis, Pfizer, Roche, sanofi-aventis
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Advice for Sponsors New to eCTD
Recently, GlobalSubmit‘s Kathie Clark took an opportunity to sit down with Cato‘s Director of Regulatory Operations, Evan Richardson, and talk about Cato’s experience with sponsors who are new to eCTD submissions. Kathie published her interview with Evan this morning in … Continue reading
