Regulatory processes orphan drugs

This FDA Orphan-Drug Review checklist has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Office of Orphan-Drug Development to critique and assess applications received. It can be used internally as a part of the Quality Assurance process, as a guideline for regulatory development of an application, and/or as a self-assessment tool to predict likely FDA response to an application. 

The competitive outcome of drug discovery is influenced by the size of the R D bnd-get (which is a major factor driving mergers in the pharmacentical field) as well as by the availability of human resources, the network of collaborative institntions and biotech companies, and the supportive regulatory environment (such as speedy registration processes and orphan drug regulation). 

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