Tag Archive: REMS

Aug 15 2012

FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Jul 16 2012

New Provisions in the FDA Safety and Innovation Act (aka PDUFA V)

Seal of the U.S. Congress

On 09 July 2012, President Obama signed FDASIA (otherwise known as PDUFA V) into law. The reauthorization of PDUFA V has been working its way through both houses of Congress since May and has received uncharacteristically broad bipartisan and bicameral support. In 2007, PDUFA IV was hotly debated between the two chambers and was barely passed in time to replace the expiring PDUFA III, but this time, lawmakers were able to meet their goal of sending the President a reconciled bill well before the 30 September expiration date of PDUFA IV.

The new law will go into effect on 01 Oct 2012 and will sunset on 30 Sept 2017.

The FDASIA includes the following provisions

Mar 08 2011

New FDA Guidances – February 2011

Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in February 2011 (links go directly to PDF documents). Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies (Draft) – Posted 17 February 2011 Medication Guides — Distribution …

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Aug 16 2010

Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective

Image via Wikipedia The Joint Statistical Meetings is often a good place to learn about emerging issues in the analysis of clinical trials (and all of the other fields that statistics touches, as a matter of fact). Here are just a few of the topics that stood out in my mind: Adaptive trials: of course, adaptive …

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Aug 16 2010

Joint Statistical Meetings 2010 Retrospective: A CRO Statistician's Perspective

Image via Wikipedia The Joint Statistical Meetings is often a good place to learn about emerging issues in the analysis of clinical trials (and all of the other fields that statistics touches, as a matter of fact). Here are just a few of the topics that stood out in my mind: Adaptive trials: of course, adaptive …

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Jun 22 2010

Free Webinar – Past, Present and Future of REMS: Can We Mitigate With Restraint?

Join Cato Research for a free educational webinar on Thursday, 24 June 2010 at 2:00 PM ET.  The webinar, titled Past, Present and Future of REMS: Can We Mitigate With Restraint?, will be presented by Jack Snyder, M.D., J.D., Ph.D., R.A.C.  Jack is a Clinical Research Physician and the Assistant Managing Director of Cato Research’s  …

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