Resolving Scientific Disputes with FDA: Regulatory Processes and Practical Tips

Posted 01 March 2011 | By Mukesh Kumar, PhD 

The US Food and Drug Administration (FDA) is a science-based organization that makes decisions based primarily upon thorough and transparent review of the scientific information provided by applicants, existing regulations and previous decisions on similar cases. However, at times, questions have been raised about FDA's conservative approach in review of new and existing products, the differences in FDA's review of a given product compared to that of other regulatory agencies, FDA's disagreements with recommendations of its own independent Advisory Committees, and the influence of political policy on FDA's decisions.

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