Monthly Archives: April 2010

Slides from “Planning for FDA Clinical Site Inspections” Webinar

Posted on 29 April 2010 by Evan Richardson

Earlier today, Cato Research Regulatory Scientist Cathy Anderson hosted a webinar titled, “Planning for FDA Clinical Site Inspections: Are You at Risk?”  Those who attended got some great practical advice, along with some real world examples of what can go … Continue reading →

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FDA Warning Letters vs Untitled Letters

Posted on 29 April 2010 by Leo DiNapoli

History is a vast early warning system. – Norman Cousins The Drug and Device Law blog recently published two short posts on FDA warning letters.  The first post mistakenly described an untitled letter, referenced in a lawsuit, as a warning … Continue reading →

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New Disclosure Requirements for FDA Advisory Committees

Posted on 28 April 2010 by Leo DiNapoli

Seldom, very seldom, does complete truth belong to any human disclosure. – Jane Austen On 21 April 2010, the FDA announced a newly revised Draft Guidance on Transparency and Advisory Committees.  If implemented, the draft guidance would increase transparency into … Continue reading →

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The Road to PDUFA V

Posted on 27 April 2010 by Leo DiNapoli

The road to success is always under construction. – Lily Tomlin At three years into the fourth iteration of the Prescription Drug User Fee Act (PDUFA), it’s time to start looking down the road towards PDFUA’s reauthorization (which will be … Continue reading →

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Pharma’s Looming Cash Flow Crunch

Posted on 26 April 2010 by Leo DiNapoli

Our greatest lack is not money for any undertaking, but rather ideas.  If the ideas are good, cash will somehow flow to where it is needed. – Robert H. Schuller Pharmalot posted a quick summary of a report by Moody’s … Continue reading →

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