Tag Archives: protocol

Regulatory Affairs Workload Increasing

Posted on 5 May 2010 by Leo DiNapoli

I would rather have a big burden and a strong back, than a weak back and a caddy to carry life’s luggage – Elbert Hubbard I don’t know if you follow the Tufts Center for the Study of Drug Development … Continue reading →

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Tips for your Special Protocol Assessment

Posted on 7 April 2010 by Leo DiNapoli

A number of scientists with greatly different backgrounds can come up with completely different assessments. – Richard Leakey One question that we hear frequently is:  Can we apply for a Special Protocol Assessment (SPA) for our Phase 3 trial?  The … Continue reading →

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Cato at MAGI’s Clinical Research Conference – 2010 East

Posted on 30 March 2010 by Evan Richardson

The MAGI Clinical Research Conference – 2010 East (MAGI2010E) will be held from 23-26 May 2010 at the Sheraton Boston Hotel in Boston, Massachusetts.  The conference will feature over 150 speakers and 92 sessions and workshops in six tracks: sponsor … Continue reading →

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Is there hope for Orphan Drug Designations in 2010?

Posted on 3 March 2010 by Leo DiNapoli

Please, sir, may I have some more? – Oliver Twist 2009 was an interesting, if not to say harrowing, year for most drug and biologic companies.  Funding sources contracted, there were major cuts in R&D programs, and pipelines narrowed.  Everyone … Continue reading →

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