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CDER Compliance Office Quality Regulatory Priorities for 2014 Include Implementing DQSA, FDASIA and Reorganization Plans

Jan 23rd, 2014

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The top priorities at FDA’s Center for Drug Evaluation and Research (CDER) compliance office in 2014 will include implementing the compounding (Title I) and track and trace (Title II) provisions of the Drug Quality and Security Act (DQSA), signed into law in late 2013, along with the ongoing implementation efforts on the generic drug user fee (Title I), supply chain (Title VII) and drug shortage (Title X) facets of the 2012 FDA Safety and Innovation Act (FDASIA).

Also on the CDER compliance office front burner for this next year will be carrying out the center’s plan to reorganize and realign its quality regulatory structures and strengthen its product and facility surveillance capabilities.

While FDA has already come forward with guidances and Federal Register notices to begin to give regulatory flesh to the Title 1 compounding provisions of DQSA (IPQ December 28, 2013), the agency has not yet formally addressed Title II. It calls for an electronic inter-operable system to identify and trace certain prescription (Rx) drugs as they are distributed through the US.

Providing a review of CDER’s current compliance priorities at the Food Drug Law Institute (FDLI) enforcement conference in Washington, D.C in December, CDER Compliance Office Director Ilisa Bernstein emphasized that the track and trace objectives called for in DQSA have been in the works for “over ten years,” and that implementation will require the agency to write guidances, publish regulations, hold public meetings, launch pilot projects, and write standards.

“We are really working hard at moving forward” on DQSA Title II implementation, Bernstein commented.

[The story continues for subscribers beginning on page 2 and includes an update on the current CDER compliance focal points.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

See related IPQ stories:

FDA Moves Quickly to Implement Compounding Provisions of Drug Quality and Security Act

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CBER Focus Intensifying on Export Certification, Adverse Event Databases, and Lab Help in Product Development

Industry Weighs in on FDASIA Title VII Importation Provisions; Participants Sought for Secure Supply Chain Pilot

FMD Implementation in Europe Drives Better API Sourcing Knowledge and Interagency Communications

FDA’s Center for Drugs Redoubles Effort to Achieve 21st Century Quality Vision and Foster Continuous Process Improvement

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System

FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

The Accelerated Recovery Initiative on Drug Shortages is Gaining Momentum – Pilot Program Underway

FDA and ISPE Seek Stakeholder Input to Improve Drug Shortage Prevention and Mitigation Strategies

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