Regulatory Focus™ > News Articles > FDA Looks to Assess Regulatory Results of Biologics Division

FDA Looks to Assess Regulatory Results of Biologics Division

Posted 05 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is preparing to launch a program to evaluate the center's review processes, and in particular how it assesses statistical data through its Division of Biostatistics (DB).

The program, explained in a contract notice posted on 23 August 2012, calls for an outside contractor to come in to evaluate the "reviewing capabilities" in the hopes of improving the regulatory review of future products. "This includes the evaluation of study protocols, and data from the resulting clinical trials as submitted by sponsors," wrote FDA.

Under the terms of the proposal, the contractor would be charged with reviewing study protocols to determine whether the data was necessary or statistically valid and whether the evidence supported the manufacturer's claims. The contractor would then highlight any deficiencies in CBER's existing reviews for further evaluation by FDA.

The contractor will also work with CBER's Division of Biostatistics (DB) to compile meta-analyses of clinical trial data and identify class-wide product concerns, including concerns related to certain types of storage conditions.

Quotes on the project are due by 6 September 2012, and FDA notes the project is estimated to take one year after the contract is awarded.


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