FDA’s Center for Veterinary Medicine Using QbR and Other CDER-Tested Approaches to Decrease Review Times; CVM User Fees Drive Guidance Development

The use by FDA’s Center for Veterinary Medicine (CVM) of a question-based review (QbR) approach in CMC submissions over the past three years has resulted in significantly decreased review times for both new and abbreviated new animal drug applications (NADAs and ANADAs) for multiple dosage forms, including sterile products – in many cases with the reviews accomplished in a single cycle.

CVM has worked closely with the Center for Drug Evaluation and Research (CDER) to implement QbR in its ongoing effort to achieve single cycle reviews and reduce the number of incomplete letters that need to be sent.  The QbR approach originated in CDER’s Office of Generic Drugs (OGD) (IPQ August 22, 2012) and is being considered for human new drug applications (NDAs) (IPQ July 2, 2013).

Another facet of CVM’s efforts to reduce animal drug review times is embodied in a draft guidance it issued in mid-October that will allow a two-phased CMC technical section submission – for example, submitting early development information for review prior to the complete package being available, or resubmitting corrections to deficiencies found in a prior approval supplement (PAS) as a “changes being effected in 30 days” filing (CBE-30).

At the PDA/FDA joint regulatory conference in Washington, DC in mid-September, CVM Director Bernadette Dunham provided an update on her office’s 2014 accomplishments and 2015 priorities. 

Dunham highlighted the industry CMC guidance documents under development and user fee initiatives that are aimed to further shorten animal drug review times from 120 days to 50 days.

She noted the wide variety of products and processes that CVM regulates on a pre- and post-approval basis, including: ● new and generic animal drugs ● animal feed and pet food ● animal devices, and ● animal drug compounding.

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