Regulatory Focus™ > News Articles > FDA Releases Guideline Q&A on Nonclinical Safety Studies for Pharmaceuticals

FDA Releases Guideline Q&A on Nonclinical Safety Studies for Pharmaceuticals

Posted 26 February 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released for comment an extensive question and answer document generated by the International Conference on Harmonisation (ICH) that is intended to clarify many aspects of a 2009 guideline on nonclinical safety studies for pharmaceutical products.

The guideline, M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answerscomes just three weeks after FDA released a similar ICH guideline on photosafety testing. That guideline is specifically intended to be read in conjunction with the M3(R2) guideline, and demonstrates how sponsors can test for whether their products induce photoallergies in patients.

ICH notes that the M3(R2) remains in the early stages of implementation, and the number and magnitude of the changes made "have generated questions that have an impact on its successful implementation."

The M3 guideline is set up as a question-and-answer (Q&A) document, and is intended to answer those questions - 54 questions spread between eight categories-to facilitate its implementation. Those categories include considerations for dose limits for toxicity studies, metabolities, reversibility of toxicity, combination drug toxicity testing, safety pharmacology, exploratory clinical trials, reproductive toxicity and juvenile animal studies.


Tags: M3(R2)

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