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FDASIA Implementation and a Sharpened Focus on Quality Head Center for Drugs’ Agenda

Apr 25th, 2013

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The impact of the FDA Safety and Innovation Act (FDASIA) on the Center for Drug Evaluation and Research (CDER) is beginning to be felt as the center comes to grips with implementing the requirements of the Act and the organizational effort it will take to meet them.

At the Food and Drug Law Institute (FDLI) annual meeting in late April in Washington, D.C., FDA Commissioner Margaret Hamburg characterized FDASIA as “a wide-ranging statute that strikes many important themes and affects numerous public health issues on FDA’s agenda.”

In addressing the meeting, CDER Director Janet Woodcock commented that over a five-year period, FDASIA places 150 specific requirements on the agency, including the promulgation of 19 regulations and 24 guidances, and 14 reports to Congress.

In passing FDASIA, Congress granted FDA important new authorities, reauthorized human drug and medical device user fees, and authorized new user fees for generic drugs and biosimilars (IPQ “The News in Depth” February 13, 2012 and September 12, 2012).

Specifically, Title VII gives FDA additional tools it has been seeking to better confront the challenges of regulating a global supply chain (IPQ “The News in Depth” October 9, 2012).  Provisions in the catch-all Title XI include a new system for the registration of medical gases and FDA participation in standard setting for nanotechnology particle-containing products that will further the Act’s impact on CMC and GMP regulatory processes (IPQ “The News in Depth” October 8, 2012).

[The story continues for subscribers beginning on page 2 and includes Woodcock’s review of the quality initiatives that CDER is undertaking in the wake of FDASIA.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

See related IPQ stories:

Pharmacy Compounding Will Remain Center Stage as FDA’s Focus Intensifies on Drug Quality, Hamburg Tells FDLI

FDASIA Title VII Empowers FDA in Supply Chain Arena; Congress Adds Other Tools to Help on Drug Shortages and Theft

FDASIA’s Catch-All Title XI Includes Provisions on Medical Gases and Nanomaterials

GDUFA Expectations for Fee Payment and Facility Registration Out for Comment; Public Meeting Scheduled

FDA Release of Biosimilar Guidance Documents Opens Up New Chapter in Dialogue with Industry

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