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FDAAA-a 5 yr safety plan

Just out: FDA's "Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan"
draft document dated March 2008.(1)

FDA will use this plan to communicate strategies FDA will follow for using PDUFA IV drug safety resources; communicate our current activity and establish measures to reports progress; and provide FDA leadership and management a foundation for understanding planned PDUFA IV drag safety activities.

A big change: FDA states that FDAAA for the first time recognizes FDA's critical role in assuring the safe and appropriate use of drugs after they are marketed, providing new resources for medical product safety, along with a variety of regulatory tools and authorities.

The Congress, consistent with many recommendations made over the past two years by the [IOM], the GAO, and a multitude of others, directs FDA to shift its regulatory paradigm to recognize that ensuring marketed drugs are used as safely and effectively as possible is equally important as getting new safe and effective drugs to market quickly and efficiently. With the goal of maintaining a systemic and scientific approach to the evaluation of benefit/risk throughout the product lifecycle, FDA must build the scientific and administrative capacity needed to become active and collaborative players in the U.S. healthcare delivery system.
Noting that typically it takes at least 2-3 years of intense training to prepare new staff to be seasoned experts in drug regulation, throughout FY 2008 and into FY2009, FDA will build staffing resources for its post-market safety activities.

FDA's PDUFA IV strategy includes improving collection and analysis of adverse event data, implementing epidemiology best practices, expanding database acquisition and use for targeted post marketing surveillance and epidemiology, strengthening risk managment and communication tools improving post market information technology systems.

(1) http://www.fda.gov/cder/pdufa/PDUFA_IV_5yr_plan_draft.pdf

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